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U.S. Department of Health and Human Services

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Enforcement Report for January 14, 2009

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

January 14, 2009
09-02

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II

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PRODUCT 
Cyanide Antidote Package, Rx only, NDC 67179-725-01 for the treatment of Cyanide Poisoning, Recall # D-164-2009
CODE
Lot: PHS 01-01
RECALLING FIRM/MANUFACTURER
Keystone Pharmaceuticals, Laguna Hills, CA, by telephone on July 25, 2008 and by letters on August 6, 2008. Firm initiated recall is complete.
REASON
Lack of Assurance of Sterility; sterile 60 mL plastic disposable syringe.
VOLUME OF PRODUCT IN COMMERCE
1,500 kits
DISTRIBUTION
Nationwide
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PRODUCT 
Fluphenazine Decanoate Injection, USP 25 mg/mL, 5 mL multiple dose vial, For IM or SC Use, Rx Only, NDC 55390-465-05, Recall # D-165-2009
CODE
Lot # 1156362, Exp Date 11/08; Lot # 1156363, Exp Date 12/08; Lot # 1181280, Exp Date 01/09; Lot # 1204958, Exp Date 01/09; Lot # 1240247, Exp Date 06/09; Lot # 1248915, Exp Date 07/09; Lot # 1254564, Exp Date 08/09; Lot # 1330276, Exp Date 11/09 & Lot # 1330277, Exp Date 11/09
RECALLING FIRM/MANUFACTURER
Ben Venue Laboratories, Inc., Bedford, OH, by letters on November 26, 2008. Firm initiated recall is ongoing.
REASON
Exceeds Impurity Specifications (6 month stability timepoint).
VOLUME OF PRODUCT IN COMMERCE
188,309 vials
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III

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PRODUCT 
Amiodarone Hydrochloride Injection 450 mg/9 mL (50 mg/mL), Must Be Diluted, For IV Use Only, 9 mL Single Use Vial, Rx only, NDC number 0703-1335-01, Recall # D-166-2009
CODE
Lot #: 07L216, exp 1/2009; 07P213, exp 2/2009; 08A204, exp 4/2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter on November 14, 2008.
Manufacturer: Teva Parenteral Medicines, Inc., Irvine, CA. Firm initiated recall is ongoing.
REASON
Exceeds Impurity Specifications (9 month stability timepoint).
VOLUME OF PRODUCT IN COMMERCE
159,133 vials
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

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PRODUCT 
Red Blood Cells, Recall # B-0315-09
CODE
Units: 4402032, 4402034, 4402031
RECALLING FIRM/MANUFACTURER
Suncoast Communities Blood Bank, Inc., Sarasota, FL, by fax or email on March 23, 2007 and March 26, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from donors whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
FL
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PRODUCT 
Red Blood Cells, Recall # B-0335-09
CODE
Unit: 6233907
RECALLING FIRM/MANUFACTURER
BloodNetUSA, Inc., Lakeland, FL, by facsimile and electronic mail on October 22, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT 
a) Fresh Frozen Plasma, Recall # B-0362-09;
b) Red Blood Cells, Leukocytes Reduced, Recall # B-0363-09;
c) Platelets Leukocytes Reduced, Recall # B-0364-09
CODE
a) Units: 019GR58259, 019GR58261;

b) Units: 019GR58244, 019GR58247, 019GR58248, 019GR58249, 019GR58250, 019GR58251, 019GR58252, 019GR58253, 019GR58254, 019GR58257, 019GR58261;

c) Units: 019GR58244, 019GR58248, 019GR58249, 019GR58251, 019GR58252, 019GR58253, 019GR58261, 019GR58263
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services Tennessee Valley Region, Nashville, TN, by facsimile on June 7, 2007. Firm initiated recall is complete.
REASON
Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.
VOLUME OF PRODUCT IN COMMERCE
21 units
DISTRIBUTION
TN, KY
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0371-09
CODE
Unit: 123769835
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on July 8, 2007.
Manufacturer: Blood Systems, Inc., Albuquerque, NM. Firm initiated recall is complete.
REASON
Blood product, which was possibly contaminated with Propionibacterium species, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NM
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PRODUCT 
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall @ B-0383-09
CODE
Unit: 019FZ35332 (Parts 1 & 2)
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services Tennessee Valley Region, Nashville, TN, by telephone on March 7, 2007 and by letter dated March 9, 2007. Firm initiated recall is complete.
REASON
Blood products,  collected using apheresis kits that had exceeded the acceptable time period for use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TN

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PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0392-09
CODE
Units: 5425275, Part A and B
RECALLING FIRM/MANUFACTURER
The Blood Center of New Jersey, East Orange, NJ, by telephone on January 27, 2007 and by follow-up letter on January 31, 2007. Firm initiated recall is complete.
REASON
Blood products, which were possibly contaminated with Peptostreptococcus Asaccharrolyticusi, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NJ

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

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PRODUCT 
Recovered Plasma, Recall # B-0316-09
CODE
Units: 4402032, 4402034, 4402031
RECALLING FIRM/MANUFACTURER
Suncoast Communities Blood Bank, Inc., Sarasota, FL, by fax or email on March 23, 2007 and March 26, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from donors whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NY
___________________________________
PRODUCT 
Red Blood Cells, Recall # B-0334-09
CODE
Unit: W050908009749
RECALLING FIRM/MANUFACTURER
HCSC Blood Center, Bethlehem, PA, by telephone on July 8, 2008. Firm initiated recall is complete.
REASON
Blood product, labeled as negative for red cell antibodies, but collected from a donor with a history of testing positive for red cell antibodies, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA
___________________________________
PRODUCT 
Recovered Plasma, Recall # B-0336-09
CODE
Unit: 6233907
RECALLING FIRM/MANUFACTURER
BloodNetUSA, Inc., Lakeland, FL, by facsimile and electronic mail on October 22, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0373-09
CODE
Unit: 123796881
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on October 29, 2007.
Manufacturer: Blood Systems, Inc., Albuquerque, NM. Firm initiated recall is complete.
REASON
Blood product, which was possibly contaminated with Diptheroid bacilli, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NM

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

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PRODUCT 
GE Healthcare Solar 8000M System, a multiparameter physiological patient monitoring system intended for use on adult, pediatric and neonatal patients, within a hospital or facility environment, Recall # Z-0285-2009
CODE

Serial numbers: PA1257732, PA1257733, PA1257734, SCZ07200027GA, SCZ07200028GA, SCZ07200029GA, SCZ07200030GA, SCZ07200031GA, SCZ07200032GA, SCZ07200033GA, SCZ07200034GA, SCZ07200035GA, SCZ07220036GA, SCZ07220037GA, SCZ07220038GA, SCZ07220039GA, SCZ07220040GA, SCZ07220041GA, SCZ07220042GA, SCZ07220043GA, SCZ07220044GA, SCZ07220045GA, SCZ07220046GA, SCZ07220047GA, SCZ07220048GA, SCZ07220049GA, SCZ07220050GA, SCZ07220051GA, SCZ07220052GA, SCZ07220053GA, SCZ07220054GA, SCZ07220055GA, SCZ07220056GA, SCZ07220058GA, SCZ07220059GA, SCZ07220060GA, SCZ07220061GA, SCZ07220067GA, SCZ07220068GA, SCZ07220069GA, SCZ07220070GA, SCZ07220072GA, SCZ07220073GA, SCZ07220076GA, SCZ07220077GA, SCZ07220078GA, SCZ07220079GA, SCZ07220080GA, SCZ07220081GA, SCZ07220082GA, SCZ07220084GA, SCZ07220085GA, SCZ07220086GA, SCZ07220087GA, SCZ07220088GA, SCZ07220089GA, SCZ07220090GA, SCZ07220091GA, SCZ07220092GA, SCZ07220093GA, SCZ07220094GA, SCZ07220095GA, SCZ07220096GA, SCZ07220097GA, SCZ07220098GA, SCZ07220099GA, SCZ07220100GA, SCZ07220101GA, SCZ07220102GA, SCZ07220103GA, SCZ07220104GA, SCZ07220105GA, SCZ07220106GA, SCZ07220107GA, SCZ07220108GA, SCZ07220109GA, SCZ07220110GA, SCZ07220111GA, SCZ07220112GA, SCZ07220113GA, SCZ07220114GA, SCZ07220115GA, SCZ07230116GA, SCZ07230158GA, SCZ07230162GA, SCZ07230163GA, SCZ07230164GA, SCZ07230165GA, SCZ07230166GA, SCZ07230167GA, SCZ07230168GA, SCZ07230169GA, SCZ07230170GA, SCZ07230171GA, SCZ07230172GA, SCZ07230173GA, SCZ07230174GA, SCZ07230175GA, SCZ07230176GA, SCZ07230177GA, SCZ07230178GA, SCZ07230179GA, SCZ07230180GA, SCZ07230181GA, SCZ07230182GA, SCZ07230183GA, SCZ07230184GA, SCZ07230185GA, SCZ07230191GA, SCZ07230209GA, SCZ07230210GA, SCZ07230211GA, SCZ07230212GA, SCZ07230213GA, SCZ07230214GA, SCZ07230215GA, SCZ07230216GA, SCZ07230217GA, SCZ07230218GA, SCZ07230219GA, SCZ07230220GA, SCZ07230221GA, SCZ07230222GA, SCZ07230223GA, SCZ07230224GA, SCZ07230225GA, SCZ07230226GA, SCZ07230227GA, SCZ07230228GA, SCZ07230229GA, SCZ07230232GA, SCZ07240255GA, SCZ07240256GA, SCZ07240257GA, SCZ07240258GA, SCZ07240259GA, SCZ07240260GA, SCZ07240261GA, SCZ07240262GA, SCZ07240263GA, SCZ07240264GA, SCZ07240265GA, SCZ07240266GA, SCZ07240267GA, SCZ07240268GA, SCZ07240269GA, SCZ07240270GA, SCZ07240271GA, SCZ07240272GA, SCZ07240273GA, SCZ07240274GA, SCZ07240275GA, SCZ07240276GA, SCZ07240277GA, SCZ07240278GA, SCZ07240279GA, SCZ07240280GA, SCZ07240281GA, SCZ07240282GA, SCZ07240283GA, SCZ07240284GA, SCZ07240285GA, SCZ07240286GA, SCZ07240287GA, SCZ07240288GA, SCZ07240289GA, SCZ07240290GA, SCZ07240291GA, SCZ07240292GA, SCZ07240293GA, SCZ07240294GA, SCZ07240295GA, SCZ07240296GA, SCZ07240297GA, SCZ07240298GA, SCZ07240299GA, SCZ07240300GA, SCZ07240301GA, SCZ07240302GA, SCZ07240303GA, SCZ07240304GA, SCZ07240306GA, SCZ07240307GA, SCZ07240308GA, SCZ07240310GA, SCZ07240321GA, SCZ07240323GA, SCZ07240324GA, SCZ07240329GA, SCZ07240346GA, SCZ07240347GA, SCZ07240348GA, SCZ07240349GA, SCZ07240350GA, SCZ07240351GA, SCZ07240352GA, SCZ07240353GA, SCZ07240387GA, SCZ07240388GA, SCZ07240391GA, SCZ07250408GA, SCZ07250409GA, SCZ07250410GA, SCZ07250411GA, SCZ07250412GA, SCZ07250413GA, SCZ07250414GA, SCZ07250415GA, SCZ07250416GA, SCZ07250417GA, SCZ07250418GA, SCZ07250419GA, SCZ07250420GA, SCZ07250421GA, SCZ07250422GA, SCZ07250423GA, SCZ07250424GA, SCZ07250436GA, SCZ07250437GA, SCZ07250438GA, SCZ07250439GA, SCZ07250440GA, SCZ07250441GA, SCZ07250442GA, SCZ07250443GA, SCZ07250444GA, SCZ07250445GA, SCZ07250446GA, SCZ07250447GA, SCZ07250448GA, SCZ07250449GA, SCZ07250450GA, SCZ07250451GA, SCZ07250452GA, SCZ07250453GA, SCZ07250454GA, SCZ07250455GA, SCZ07250456GA, SCZ07250457GA, SCZ07250458GA, SCZ07250459GA, SCZ07250460GA, SCZ07250461GA, SCZ07250462GA, SCZ07250463GA, SCZ07250464GA, SCZ07250465GA, SCZ07250466GA, SCZ07250467GA, SCZ07250468GA, SCZ07250469GA, SCZ07250470GA, SCZ07280733GA, SCZ07280734GA, SCZ07280735GA, SCZ07280736GA, SCZ07280737GA, SCZ07280738GA, SCZ07280739GA, SCZ07280741GA, SCZ07280742GA, SCZ07280746GA, SCZ07280747GA, SCZ07280749GA, SCZ07280753GA, SCZ07280754GA, SCZ07280755GA, SCZ07280756GA, SCZ07280757GA, SCZ07280758GA, SCZ07280759GA, SCZ07280760GA, SCZ07280761GA, SCZ07280762GA, SCZ07280763GA, SCZ07280764GA, SCZ07280765GA, SCZ07280766GA, SCZ07280767GA, SCZ07280768GA, SCZ07280769GA, SCZ07280770GA, SCZ07280771GA, SCZ07280772GA, SCZ07280773GA, SCZ07280774GA, SCZ07280775GA, SCZ07280776GA, SCZ07280777GA, SCZ07280778GA, SCZ07280779GA, SCZ07280780GA, SCZ07280781GA, SCZ07280782GA, SCZ07280783GA, SCZ07280784GA, SCZ07280785GA, SCZ07280786GA, SCZ07280787GA, SCZ07280788GA, SCZ07280789GA, SCZ07280790GA, SCZ07280791GA, SCZ07280792GA, SCZ07280793GA, SCZ07280794GA, SCZ07280795GA, SCZ07280796GA, SCZ07280797GA, SCZ07280798GA, SCZ07280802GA, SCZ07280803GA, SCZ07280809GA, SCZ07280810GA, SCZ07280811GA, SCZ07280812GA, SCZ07280813GA, SCZ07280814GA, SCZ07280815GA, SCZ07280816GA, SCZ07280817GA, SCZ07280818GA, SCZ07280819GA, SCZ07280820GA, SCZ07280821GA, SCZ07280822GA, SCZ07280823GA, SCZ07280824GA, SCZ07280825GA, SCZ07280826GA, SCZ07280827GA, SCZ07280828GA, SCZ07280829GA, SCZ07280830GA, SCZ07290860GR, SCZ07290861GA, SCZ07290862GA, SCZ07290863GA, SCZ07290864GA, SCZ07290865GA, SCZ07290866GA, SCZ07290867GA, SCZ07290868GA, SCZ07290869GA, SCZ07290870GA, SCZ07290871GA, SCZ07290872GA, SCZ07290873GA, SCZ07290874GA, SCZ07290875GA, SCZ07290876GA, SCZ07290877GA, SCZ07290878GA, SCZ07290879GA, SCZ07290880GA, SCZ07290881GA, SCZ07290882GA, SCZ07290883GA, SCZ07290884GA, SCZ07290885GA, SCZ07290886GA, SCZ07290887GA, SCZ07290888GA, SCZ07290889GA, SCZ07290890GA, SCZ07290891GA, SCZ07290892GA, SCZ07290893GA, SCZ07290894GA, SCZ07290895GA, SCZ07290896GA, SCZ07290897GA, SCZ07290898GA, SCZ07290899GA, SCZ07290900GA, SCZ07290901GA, SCZ07290902GA, SCZ07290903GA, SCZ07290904GA, SCZ07290905GA, SCZ07290906GA, SCZ07290907GA, SCZ07290908GA, SCZ07290909GA, SCZ07290910GA, SCZ07290911GA, SCZ07290912GA, SCZ07290913GA, SCZ07290914GA, SCZ07290915GA, SCZ07290917GA, SCZ07290919GA, SCZ07290920GA, SCZ07290921GA, SCZ07290922GA, SCZ07290923GA, SCZ07290924GA, SCZ07290926GA, SCZ07290927GA, SCZ07290930GA, SCZ07290931GA, SCZ07290932GA, SCZ07290933GA, SCZ07290934GA, SCZ07290935GA, SCZ07290936GA, SCZ07300937GA, SCZ07300938GA, SCZ07300939GA, SCZ07300940GA, SCZ07300941GA, SCZ07300942GA, SCZ07300943GA, SCZ07300944GA, SCZ07300945GA, SCZ07300946GA, SCZ07300947GA, SCZ07300948GA, SCZ07300949GA, SCZ07300950GA, SCZ07300951GA, SCZ07300952GA, SCZ07300953GA, SCZ07300954GA, SCZ07300955GA, SCZ07300956GA, SCZ07300957GA, SCZ07300958GA, SCZ07300959GA, SCZ07300960GA, SCZ07300961GA, SCZ07300962GA, SCZ07300963GA, SCZ07300964GA, SCZ07300965GA, SCZ07300966GA, SCZ07300967GA, SCZ07300968GA, SCZ07300969GA, SCZ07300970GA, SCZ07300971GA, SCZ07300972GA, SCZ07300973GA, SCZ07300974GA, SCZ07300975GA, SCZ07300976GA, SCZ07300977GA, SCZ07300978GA, SCZ07300979GA, SCZ07300980GA, SCZ07300981GA, SCZ07300982GA, SCZ07300983GA, SCZ07300984GA, SCZ07300985GA, SCZ07300986GA, SCZ07300987GA, SCZ07300991GA, SCZ07300992GA, SCZ07300993GA, SCZ07300994GA, SCZ07300995GA, SCZ07300996GA, SCZ07300997GA, SCZ07300998GA, SCZ07300999GA, SCZ07301000GA, SCZ07301001GA, SCZ07301002GA, SCZ07311138GA, SCZ07311139GA, SCZ07311140GA, SCZ07311141GA, SCZ07311142GA, SCZ07311143GA, SCZ07311144GA, SCZ07311145GA, SCZ07311146GA, SCZ07311147GA, SCZ07311148GA, SCZ07311149GA, SCZ07311150GA, SCZ07311151GA, SCZ07311152GA, SCZ07311153GA, SCZ07311154GA, SCZ07311155GA, SCZ07311156GA, SCZ07311157GA, SCZ07311158GA, SCZ07311159GA, SCZ07311160GA, SCZ07311161GA, SCZ07311162GA, SCZ07311163GA, SCZ07311166GA, SCZ07311167GA, SCZ07311168GA, SCZ07311169GA, SCZ07311170GA, SCZ07311171GA, SCZ07311172GA, SCZ07311173GA, SCZ07311174GA, SCZ07311175GA, SCZ07311176GA, SCZ07311177GA, SCZ07311178GA, SCZ07311179GA, SCZ07311180GA, SCZ07311181GA, SCZ07311182GA, SCZ07311183GA, SCZ07311184GA, SCZ07311185GA, SCZ07311186GA, SCZ07311187GA, SCZ07311188GA, SCZ07311189GA, SCZ07311190GA, SCZ07311191GA, SCZ07311192GA, SCZ07311193GA, SCZ07311194GA, SCZ07311195GA, SCZ07311196GA, SCZ07311197GA, SCZ07311198GA, SCZ07311199GA, SCZ07311200GA, SCZ07311201GA, SCZ07311202GA, SCZ07311203GA, SCZ07311204GA, SCZ07311205GA, SCZ07311206GA, SCZ07311207GA, SCZ07311208GA, SCZ07311209GA, SCZ07311210GA, SCZ07311211GA, SCZ07311212GA, SCZ07311213GA, SCZ07311214GA, SCZ07311215GA, SCZ07311216GA, SCZ07311217GA, SCZ07311218GA, SCZ07311219GA, SCZ07311220GA, SCZ07311221GA, SCZ07311222GA, SCZ07311223GA, SCZ07311224GA, SCZ07311225GA, SCZ07311226GA, SCZ07311227GA, SCZ07311228GA, SCZ07311229GA, SCZ07311230GA, SCZ07311231GA, SCZ07311232GA, SCZ07311233GA, SCZ07311234GA, SCZ07311235GA, SCZ07311236GA, SCZ07311237GA, SCZ07311238GA, SCZ07311239GA, SCZ07311240GA, SCZ07311241GA, SCZ07311242GA, SCZ07311243GA, SCZ07311244GA, SCZ07311245GA, SCZ07311246GA, SCZ07311247GA, SCZ07311248GA, SCZ07311249GA, SCZ07311250GA, SCZ07311251GA, SCZ07311252GA, SCZ07311253GA, SCZ07311254GA, SCZ07311255GA, SCZ07311256GA, SCZ07311257GA, SCZ07311258GA, SCZ07321282GA, SCZ07321283GA, SCZ07321284GA, SCZ07321285GA, SCZ07321286GA, SCZ07321287GA, SCZ07321288GA, SCZ07321289GA, SCZ07321337GA, SCZ07321338GA, SCZ07341347GA, SCZ07341348GA, SCZ07341349GA, SCZ07341350GA, SCZ07341351GA, SCZ07341352GA, SCZ07341353GA, SCZ07341354GA, SCZ07341355GA, SCZ07341360GA, SCZ07341361GA, SCZ07341362GA, SCZ07341363GA, SCZ07341364GA, SCZ07341365GA, SCZ07341366GA, SCZ07341367GA, SCZ07341368GA, SCZ07341369GA, SCZ07341370GA, SCZ07341386GA, SCZ07341387GA, SCZ07341388GA, SCZ07341389GA, SCZ07341390GA, SCZ07341391GA, SCZ07341392GA, SCZ07341393GA, SCZ07341394GA, SCZ07341395GA, SCZ07341396GA, SCZ07341397GA, SCZ07341398GA, SCZ07341399GA, SCZ07341400GA, SCZ07341401GA, SCZ07341402GA, SCZ07341403GA, SCZ07341404GA, SCZ07341405GA, SCZ07341406GA, SCZ07341407GA, SCZ07341408GA, SCZ07341409GA, SCZ07341410GA, SCZ07341411GA, SCZ07341412GA, SCZ07341413GA, SCZ07341414GA, SCZ07341415GA, SCZ07341416GA, SCZ07341417GA, SCZ07341418GA, SCZ07341419GA, SCZ07341420GA, SCZ07341421GA, SCZ07341422GA, SCZ07341423GA, SCZ07341424GA, SCZ07341425GA, SCZ07351442GA, SCZ07361506GA, SCZ07361507GA, SCZ07361508GA, SCZ07361509GA, SCZ07361510GA, SCZ07361511GA, SCZ07361512GA, SCZ07361513GA, SCZ07361514GA, SCZ07361515GA, SCZ07361516GA, SCZ07361517GA, SCZ07361518GA, SCZ07361519GA, SCZ07361520GA, SCZ07361521GA, SCZ07361522GA, SCZ07361523GA, SCZ07361524GA, SCZ07361525GA, SCZ07361526GA, SCZ07361527GA, SCZ07361528GA, SCZ07361529GA, SCZ07361530GA, SCZ07361531GA, SCZ07361532GA, SCZ07361533GA, SCZ07361534GA, SCZ07361535GA, SCZ07361536GA, SCZ07361537GA, SCZ07361538GA, SCZ07361539GA, SCZ07361540GA, SCZ07361541GA, SCZ07361542GA, SCZ07361543GA, SCZ07361544GA, SCZ07361545GA, SCZ07361546GA, SCZ07361547GA, SCZ07361548GA, SCZ07361549GA, SCZ07361550GA, SCZ07361551GA, SCZ07361552GA, SCZ07361553GA, SCZ07361555GA, SCZ07361637GA, SCZ07371685GA, SCZ07371687GA, SCZ07371692GA, SCZ07371696GA, SCZ07371697GA, SCZ07371698GA, SCZ07371699GA, SCZ07371700GA, SCZ07371701GA, SCZ07371702GA, SCZ07371703GA, SCZ07371704GA, SCZ07371705GA, SCZ07371706GA, SCZ07371707GA, SCZ07371708GA, SCZ07371709GA, 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SE408100951GA, SE408100952GA, SE408100953GA, SE408100954GA, SE408110981GA, SE408111040GA, SE408111044GA, SE408111203GA, SE408111206GA, and SE408111209GA
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare, Wauwatose, WI, by letter dated August 26, 2008.
Manufacturer: General Electric Medical Systems Information Technology, Milwaukee, WI. Firm initiated recall is ongoing.
REASON
A software error has been discovered when using Combination Monitoring with Solar 8000M/I – PDM – Telemetry in combo mode. This error has only been noted with this particular configuration and mode of monitoring.
VOLUME OF PRODUCT IN COMMERCE
2,782 units
DISTRIBUTION
Nationwide and Australia, Austria, Belgium, Brazil, Czech Republic, Denmark, Egypt, France, Germany, Indonesia, Ireland, Italy, Jordan, Korea, Lebanon, Lithuania, Malaysia, Netherlands, Norway, Pakistan, Saudi Arabia, Spain, Sweden, United Kingdom, and Venezuela
___________________________________
PRODUCT 
a) Somatom Sensation 40 X-Ray System, Model number 8874427. This is a computed tomography x-ray system which is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles, Recall # Z-0320-2009;

b) Somatom Sensation 64 X-Ray System, Model number 8377520. This is a computed tomography x-ray system which is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles, Recall # Z-0321-2009
CODE
a) Serial numbers: 54016, 54027, 54031, 54033, 54035,54045, 54049, 54050, 54051, 54052, 54056, 54060, 54062, 54064, 54074, 54075, 54085, 54094, 54104, 54108, 54119, 54127, 54129, 54137, 54140, 54144, 54146, 54148, 54154, 54156, 54170, 54172, 54175, 54180, 54186, 54193, 54194, 54198, 54203, 54204, 54219, 54220, 54221, 54222, 54229, 54233, 54248, 54250, 54253, 54254, 54258, 54271, 54306, 54307, 54309 54319, 54325, 54419, 54677, 54684, 54690, 55019, 55022, 55023, 55024, 55035, 55041, 55043, 55047, 55061, 55063,55066, 55070, 55071, 55075, 55080, 55081, 55082, 55090, 55093, 55097, 55100, 55102, 55103, 55110, 55111, 55113, 55115, 55116, 55121, 55122, 55123, 55138, 55141, 55144, 55149, 55156, 55158, 55166, 55172, 55179, 55182, 55183, 55189, 55194, 55207, 55209, 55211, 55230, 55246, 55249, 55250, 55260, 55261, 55265, 55269, 55270, 55274, 55275, 55279, 55283, 55284, 55285, 55286, 55295, 55308, 55309, 55310, 55311, 55316, 55319, 55322, 55325, 55332, 55333, 55336, 55344, 55353, 55357, 55360, 55363, 55369, 55373, 55377, 55385, 55389, 55393, 55398, 55404, 55405, 55406, 55407, 55415, 55416, 55417, 55422, 55423, 55424, 55426, 55428, 55429, 55434, 55440, 55448, 55454, 55455, 55457, 55458, 55466, and 55467;

b) Serial numbers 57084, 57193, 57213, 57261, 57262, 57270, 57272, 57285, and 57298
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter on September 3, 2008.
Manufacturer: Siemens AG, Medical Solution, Forchheim, Germany. Firm initiated recall is ongoing.
REASON
Software error – does not allow protocol to properly synchronize with ECG triggers.
VOLUME OF PRODUCT IN COMMERCE
177 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
FS-OMNI, Fusion Omni-Tome, Sterile, Rx only. The Fusion Omni-Tome is supplied sterile and is a single use device. This device is used in cannulation of the ductal system and for sphincterotomy, Recall # Z-0325-2009
CODE
Lot: W2501093
RECALLING FIRM/MANUFACTURER
Cook Endoscopy, Winston Salem, NC, by email on October 30, 20008. Firm initiated recall is ongoing.
REASON
The wire control port may have been omitted during manufacture.
VOLUME OF PRODUCT IN COMMERCE
11 devices
DISTRIBUTION
Ireland
___________________________________
PRODUCT 
ThomoTherapy HI-ART Systems with 3.1.2, 3.1.3 or 3.2.1 software. The affected applications include Planning Station, Planned Adaptive, Data Management System, and TomoPortal. The product is intended for use in radiation therapy, Recall # Z-0339-2009
CODE
USA 110001 110002 110003 110004 110005 110006 110007 110008 110012 110015 110016 110019 110020 110021 110023 110026 110027 110028 110029 110030 110031 110032 110033 110035 110038 110040 110042 110043 110044 110045 110047 110048 110050 110051 110053 110054 110056 110057 110059 110060 110067 110073 110074 110082 110084 110086 110087 110089 110090 110092 110094 110095 110096 110097 110098 110103 110105 110106 110108 110112 110115 110116 110118 110119 110120 110122 110127 110132 110134 110135 110138 110139 110149 110152 110153 110154 110155 110158 110160 110161 110165 110166 110168 110173 110174 110175 110176 110177 110179 110180 110181 110185 110186 110187 110188 110190 110192 110193 110195 110196 110197 110198 110201 110202 110203 110204 110206 110209 110210 110213 110215 110216 110217 110221 110222 110223 110224 110225 110227 110242 and 110250
Internationally - 110034 110062 110083 110126 110140 110014 110037 110072 110130 110169 110137 110077 110111 110117 110123 110146 110151 110189 110114 110131 110143 110170 110061 110167 110228 110157 110018 110071 110136 110162 110171 110211 110199 110150 110178 110237 110068 110078 110194 110069 110110 110191 110207 and 110240
RECALLING FIRM/MANUFACTURER
TomoTherapy, Inc., Madison, WI, by letter dated September 17, 2008. Firm initiated recall is ongoing.
REASON
Treatment plans involving very small structures (volume <2cc), reading in a high dose gradient region, may exhibit inaccuracies with the DVH curve and the Dose Statistics for the small structures. The error can result in up to 30% inaccuracy in the DVH curve and Dose Statistics.
VOLUME OF PRODUCT IN COMMERCE
165 units
DISTRIBUTION
Nationwide, Belgium, Canada, Switzerland, Germany, Spain, France, Great Britain, India, Italy, Japan, Korea, Netherlands, Turkey, and Taiwan
___________________________________
PRODUCT 
a) GE OEC 9900 Elite ESP fluoroscopic x-ray system. The system is intended to provide an x-ray display of human anatomy, Recall # Z-0341-2009;

b) GE OEC 9900 Elite GSP fluoroscopic x-ray system. The system is intended to provide an x-ray display of human anatomy, Recall # Z-0342-2009
CODE
a) E2-0033, E2-0060 E2-0077, E2-0101, E2-0102, E2-0106, E2-0113, E2-0189, E2-0198, E2-0202, E2-0244, E2-0253, E2-0258, E2-0262, E2-0264, E2-0266, E2-0268, E2-0270, E2-0271 E2-0272, E2-0273, E2-0274, . E2-0281, E2-0283, E2-0284, E2-0285, E2-0288, E2-0289, E2-0290, E2-0291, E2-0293, E2-0294, E2-0296, E2-0297, E2-0298, E2-0300, E2-0302, E2-0303, E2-0304, E2-0305, E2-0308, E2-0310, E2-0311, E2-0312, E2-0314, E2-0315, E2-0317, E2-0317, E2-0318, E2-0319, E2-0320, E2-0321, E2-0322, E2-0323, E2-0325, E2-0327, E2-0330, E2-0332, E2-0333, E2-0335, E2-0337, E2-0338, E2-0340, E2-0341, E2-0342, E2-0345 E2-0346, E2-0348, E2-0349, E2-0351, E2-0354, E2-0357, E2-0360, E2-0361, E2-0363, E2-0364, E2-0365 E2-0366, E2-0368, E2-0369, E2-0370, E2-0371, E2-0372, E2-0373, E2-0376, E2-0377, E2-0378 E2-0379, E2-0380, E2-0381, E2-0383, E2-0384, E2-0385, E2-0386, E2-0387, E2-0389, E2-0390, E2-0391, E2-0392, E2-0393, E2-0394, E2-0396, E2-0398, E2-0399, E2-0400, E2-0401, E2-0402, E2-0403, E2-0404, E2-0405, E2-0406, E2-0407, E2-0408, E2-0409, E2-0410, E2-0412, E2-0413, E2-0414, E2-0415, E2-0416, E2-0417, E2-0418, E2-0419, E2-0420, E2-0421, E2-0422, E2-0423, E2-0424, E2-0425, E2-0426, E2-0427, E2-0428, E2-0429, E2-0430, E2-0431, E2-0432, E2-0433, E2-0434, E2-0435, E2-0436, E2-0437, E2-0438, E2-0439, E2-0440, E2-0441, E2-0442, E2-0443, E2-0445, E2-0448, E2-0449 E2-0451, E2-0452, E2-0453, E2-0454, E2-0455, E2-0456, E2-0457, E2-0458, E2-0459, E2-0461, E2-0462, E2-0463, E2-0465, E2-0466, E2-0467, E2-0468, E2-0469, E2-0470, E2-0471, E2-0472, E2-0473, E2-0474, E2-0475, E2-0478, E2-0482, E2-0483, E2-0485, E2-0488, E2-0489, E2-0490, E2-0494, E2-0496, E2-0497, E2-0498, E2-0499, E2-0502, E2-0503, E2-0504, E2-0507, E2-0509, E2-0512, E2-0513, E2-0519, E2-0520, E2-0525, E2-0526, E2-0529, E2-0530, E2-0532, E2-0534, E2-0535, E2-0537, E2-0538, E2-0540, E2-0541, E2-0542, E2-0546, E2-0549, and E2-7022-MH, E9-0002-G E9-0018, E9-0025, E9-0030, E9-0035-G, E9-0043, E9-0055, E9-0066, E9-0092, E9-0094, E9-0095, E9-0098, E9-0099, E9-0101, E9-0103, E9-0107, E9-0108, E9-0109, E9-0110, E9-0119, E9-0121, E9-0124, E9-0129, E9-0137, E9-0138, E9-0140, E9-0144, E9-0145, E9-0150, E9-0159, E9-0163, E9-0166, E9-0168, E9-0169 E9-0171, E9-0172, E9-0173, E9-0174, E9-0175, E9-0176, E9-0177, E9-0178, E9-0179, E9-0185, E9-0186, E9-0187, E9-0190, E9-0191, E9-0192, E9-0194, E9-0195, E9-0197, E9-0198, E9-0201, E9-0203, E9-0204, E9-0205, E9-0206, E9-0207, E9-0208, E9-0210, E9-0212, E9-0214, E9-0215, E9-0216, E9-0218, E9-0219, E9-0220, E9-0224, E9-0225, E9-0228, E9-0231, E9-0232, E9-0233, E9-0234, E9-0235, E9-0236, E9-0237, E9-0238, E9-0239, E9-0240, E9-0241, E9-0242, E9-0243, E9-0244, E9-0245, E9-0246, E9-0255, E9-0257, E9-0258, E9-0266, E9-0267, E9-0268, E9-0270, E9-0275, E9-0277, E9-0280, E9-0282, E9-0283, E9-0284, E9-0285, E9-0289, E9-0290, E9-0292, E9-0294, E9-0300, E9-0301, E9-0306, E9-0307, E9-0309, E9-0313, E9-0314, E9-0316, E9-0327, E9-0329, E9-0332, E9-0334, E9-0341, E9-0353, E9-0354, E9-0357, E9-0363, E9-0372, E9-0373, E9-0375, E9-0384, E9-0388, E9-0390, E9-0391, E9-0393, E9-0394, E9-0396, E9-0398, E9-0400, E9-0403, E9-0404, E9-0405, E9-0406, E9-0407, E9-0410, E9-0411, E9-0416, E9-0417, E9-0419, E9-0420, E9-0421, E9-0424, E9-0425, E9-0426, E9-0429, E9-0436, E9-0441, E9-0443, E9-0444, E9-0445, E9-0446, E9-0447, E9-0448, E9-0449, E9-0450, E9-0452, E9-0456, E9-0457, E9-0458, E9-0459, E9-0461, E9-0463, E9-0464, E9-0465, E9-0466, E9-0471, E9-0472, E9-0474, E9-0475, E9-0477, E9-0479, E9-0481, E9-0482, E9-0483, E9-0486, E9-0488, E9-0492, E9-0494, E9-0495, E9-0497, E9-0499, E9-0501, E9-0502, E9-0511, E9-0513, E9-0515, E9-0516, E9-0524, E9-0530, E9-0532, E9-0533, E9-0540, E9-0541, E9-0542, E9-0543, E9-0545, E9-0551, E9-0554, and E9-0557, ES-0013-G, ES-0019, ES-0050, ES-0054, ES-0103, ES-0110, ES-0113, ES-0114, ES-0115, ES-0117, ES-0118, ES-0130, ES-0134, ES-0160, ES-0176, ES-0180, ES-0188, ES-0189, ES-0192, ES-0198, ES-0199, ES-0203, ES-0206, ES-0207, ES-0211, ES-0216, ES-0217, ES-0218, ES-0219, ES-0220, ES-0224, ES-0225, ES-0226, ES-0227, ES-0228, ES-0234, ES-0236, ES-0238, ES-0239, ES-0253, ES-0254, ES-0255, ES-0262, ES-0266, ES-0272, ES-0273, ES-0274, ES-0275, ES-0279, ES-0280, ES-0281, ES-0292, ES-0299, ES-0300, ES-0312, ES-0316, ES-0321, ES-0322, ES-0326, ES-0332, ES-0335, ES-0336, ES-0337, ES-0342, ES-0343, ES-0349, ES-0351, ES-0352, ES-0354, ES-0355, ES-0358, ES-0359, ES-0360, ES-0363, ES-0364, ES-0365, ES-0366, ES-0367, ES-0374, ES-0375, ES-0376, ES-0377, ES-0378, ES-0379, ES-0380, ES-0381, ES-0382, ES-0383, ES-0384, ES-0385, ES-0387, ES-0390, ES-0391, ES-0394, ES-0396, ES-0399, ES-0400, ES-0401, ES-0402, ES-0403, ES-0404, ES-0405, ES-0412, ES-0413, ES-0415, ES-0417, ES-0418, ES-0419, ES-0421, ES-0422, ES-0423, ES-0425, ES-0427, ES-0428, ES-0429, ES-0430, ES-0431, ES-0433, ES-0434, ES-0435, ES-0436, ES-0437, ES-0438, ES-0439, ES-0441, ES-0442, ES-0443, ES-0444, ES-0445, ES-0446, ES-0450, ES-0451, ES-0452, ES-0454, ES-0455, ES-0458, ES-0459, ES-0460, ES-0462, ES-0463, ES-0464, ES-0465, ES-0467, ES-0468, ES-0469, ES-0472, ES-0476, ES-0478, ES-0479, ES-0480, ES-0482, ES-0483, ES-0484, ES-0485, ES-0486, ES-0487, ES-0488, ES-0490, ES-0493, ES-0494, ES-0495, ES-0496, ES-0497, ES-0498, ES-0499, ES-0500, ES-0501, ES-0502, ES-0509, ES-0510, ES-0513, ES-0514, ES-0515, ES-0518, ES-0521, ES-0522, ES-0523, ES-0526, ES-0527, ES-0528, ES-0529, ES-0532, ES-0533, ES-0536, ES-0538, ES-0544, ES-0547, ES-0549, ES-0552, ES-0553, and ES-0561;

b) E2-0027, E2-0047-RC, E2-0067, E2-0086, E2-0110, E2-0117, E2-0136, E2-0137, E2-0162, E2-0175, E2-0194, E2-0245, E2-0295, E2-0326, E2-0334, E2-0336, E2-0339, E2-0343, E2-0344, E2-0347, E2-0350, E2-0353, E2-0355, E2-0356, E2-0358, E2-0359, E2-0362, E2-0367, E2-0374, E2-0375, E2-0382, E2-0388, E2-0395, E2-0397, E2-0411, E2-0464, E2-0476, E2-0479, E2-0480, E2-0481, E2-0487, E2-0491, E2-0500, and E2-0501, E9-0010, E9-0011, E9-0013, E9-0019, E9-0023, E9-0026, E9-0028, E9-0036-G, E9-0039, E9-0040-G, E9-0045, E9-0048, E9-0049, E9-0057, E9-0058, E9-0063, E9-0064, E9-0067, E9-0071, E9-0078, E9-0080, E9-0081, E9-0082, E9-0083, E9-0086, E9-0088, E9-0093, E9-0115, E9-0116, E9-0120, E9-0123, E9-0126, E9-0130, E9-0141, E9-0143, E9-0149, E9-0153, E9-0155, E9-0156, E9-0156, E9-0157 E9-0158, E9-0167, E9-0180, E9-0181, E9-0184, E9-0196, E9-0202, E9-0217, E9-0221, E9-0222, E9-0223, E9-0226, E9-0227, E9-0229, E9-0230, E9-0256, E9-0259, E9-0263, E9-0269, E9-0271, E9-0272, E9-0273, E9-0274, E9-0276, E9-0278, E9-0279, E9-0281, E9-0286, E9-0287, E9-0288, E9-0291, E9-0293, E9-0295, E9-0296, E9-0297, E9-0298, E9-0299, E9-0302, E9-0303, E9-0304, E9-0305, E9-0308, E9-0310, E9-0311, E9-0312, E9-0315, E9-0317, E9-0318, E9-0319, E9-0320, E9-0321, E9-0322, E9-0323, E9-0324, E9-0325, E9-0326, E9-0328, E9-0330, E9-0331, E9-0333, E9-0335, E9-0336, E9-0337, E9-0338, E9-0339, E9-0340, E9-0342, E9-0343, E9-0344, E9-0345, E9-0346, E9-0347, E9-0348, E9-0349, E9-0350, E9-0351, E9-0352, E9-0355, E9-0356, E9-0358, E9-0359, E9-0360, E9-0361, E9-0362, E9-0364, E9-0365, E9-0366, E9-0367, E9-0368, E9-0369, E9-0370, E9-0371, E9-0374, E9-0376, E9-0377, E9-0378, E9-0379, E9-0380, E9-0381, E9-0382, E9-0383, E9-0385, E9-0386, E9-0387, E9-0389, E9-0392, E9-0397, E9-0399, E9-0401, E9-0402, E9-0408, E9-0409, E9-0411, E9-0412, E9-0413, E9-0414, E9-0415, E9-0418, E9-0422, E9-0423, E9-0427, E9-0428, E9-0430, E9-0431, E9-0432, E9-0433, E9-0434, E9-0435, E9-0437, E9-0438, E9-0439, E9-0440, E9-0442, E9-0451, E9-0454, E9-0455, E9-0460, E9-0467, E9-0468, E9-0469, E9-0470, E9-0473, E9-0476, E9-0478, E9-0480, E9-0484, E9-0485, E9-0487, E9-0489, E9-0490, E9-0491, E9-0496, E9-0500, E9-0503, E9-0508, E9-0510, E9-0512, E9-0517, E9-0518, E9-0520, E9-0521, E9-0526, E9-0528, E9-0537, E9-0538, E9-0544, E9-0549, and E9-0009, ES-0029-CH ES-0030, ES-0037, ES-0039, ES-0048, ES-0051, ES-0057, ES-0060-H, ES-0064, ES-0065, ES-0066-CH ES-0073, ES-0076, ES-0089, ES-0090, ES-0096, ES-0106, ES-0108, ES-0120, ES-0121, ES-0123, ES-0124, ES-0125, ES-0126, ES-0128, ES-0135, ES-0139, ES-0147, ES-0170, ES-0172, ES-0181, ES-0183, ES-0187, ES-0197, ES-0208, ES-0213, ES-0214, ES-0215, ES-0221, ES-0222, ES-0223, ES-0229, ES-0230, ES-0231, ES-0232, ES-0233, ES-0235, ES-0237, ES-0240, ES-0241, ES-0243, ES-0244, ES-0247, ES-0248, ES-0249, ES-0250, ES-0251, ES-0252, ES-0256, ES-0257, ES-0258, ES-0259, ES-0260, ES-0261, ES-0263, ES-0264, ES-0265, ES-0267, ES-0268, ES-0269, ES-0270, ES-0271, ES-0276, ES-0277, ES-0278, ES-0282, ES-0283, ES-0284, ES-0285, ES-0286, ES-0287, ES-0288, ES-0289, ES-0290, ES-0291, ES-0293, ES-0294, ES-0295, ES-0296, ES-0297, ES-0298, ES-0301, ES-0302, ES-0303, ES-0304, ES-0305, ES-0306, ES-0307, ES-0308, ES-0309, ES-0310, ES-0311, ES-0313, ES-0314, ES-0315, ES-0317, ES-0318, ES-0319, ES-0320, ES-0323, ES-0324, ES-0325, ES-0327, ES-0328, ES-0329, ES-0330, ES-0331, ES-0333, ES-0334, ES-0338, ES-0339, ES-0340, ES-0341, ES-0344, ES-0345, ES-0346, ES-0347, ES-0348, ES-0350, ES-0353, ES-0356, ES-0357, ES-0361, ES-0362, ES-0368, ES-0369, ES-0370, ES-0371, ES-0372, ES-0373, ES-0386, ES-0388, ES-0389, ES-0392, ES-0393, ES-0395, ES-0396 ES-0397, ES-0398, ES-0406, ES-0407, ES-0408, ES-0409, ES-0410, ES-0411, ES-0414, ES-0416, ES-0420, ES-0424, ES-0426, ES-0432, ES-0440, ES-0447, ES-0448, ES-0449, ES-0453, ES-0457, ES-0466, ES-0470, ES-0471, ES-0473, ES-0474, ES-0475, ES-0477, ES-0481, ES-0489, ES-0491, ES-0492, ES-0503, ES-0504, ES-0505, ES-0507, ES-0508, ES-0516, ES-0517, ES-0519, ES-0520, ES-0530, ES-0531, ES-0537, ES-0540, ES-0542, ES-0543, ES-0546, ES-0548, ES-7002-MH, and ES-7029-MH
RECALLING FIRM/MANUFACTURER
OEC Medical Systems, Inc., Salt Lake City, UT, by letter on August 29, 2008. Firm initiated recall is ongoing.
REASON
Under certain conditions, x-ray system may experience operational impairment.
VOLUME OF PRODUCT IN COMMERCE
1,017 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
a) SteriLyte® Liquid Bicarbinate, Formula CL-02; 1 gallon (3.78 L). This product is used in conjunction with C-Series RenalPure® Liquid Acid Concentrate or DC-Series Dri-Sate® Dry Acid Concentrate in artificial kidney (hemodialysis) machines, Recall # Z-0439-2009;

b) SteriLyte® Liquid Bicarbinate, Formula RL-01; 1 gallon (3.78 L). This product is used in conjunction with C-Series RenalPure® Liquid Acid Concentrate or DC-Series Dri-Sate® Dry Acid Concentrate in artificial kidney (hemodialysis) machines, Recall # Z-0440-2009
CODE
a) Lots: 10442, 10461 and 10462;
b) Lot: 10445
RECALLING FIRM/MANUFACTURER
Rockwell Medical Technologies, Inc., Grapevine, TX, by fax and/or email on September 29, 2008 and by letter on September 30, 2008. Firm initiated recall is ongoing.
REASON
Microbial growth was observed in the retain samples of 4 lots of Liquid Bicarbonate after products had been distributed.
VOLUME OF PRODUCT IN COMMERCE
12,452/1 gallon containers
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Homocysteine Reagent Test Kit. The Homocysteine test kits were manufactured under 2 brand names. The first brand name a) Catch, the label reads "CATCH Catch Inc., HOMOCYSTEINE REAGENT KIT, Catalog Number A11167, 100 Test Kit, The kit is made up of 5 individual portions. These include: Homocysteine Reagent R1 HCY A (28mL), Homocysteine Reagent R2 HCY R2 (13.5 mL), Homocysteine HCY C (2.8 mL), Homocysteine 0.0 umol/L (2mL) and Homocysteine 27.0 umol/L (2mL).
b) The second brand name Equal the label reads "EQual DIAGNOSTICS FOR IN VITRO DIAGNOSTIC USE ONLY HOMOCYSTEINE 3-Part Kit w/calibrators, Catalog Number E02-058-03, The kit is made up of 5 individual portions. These include: Homocysteine Reagent R1, Homocysteine Reagent R2, Homocysteine Reagent R3, Homocysteine Calibrator 0.0 umol/L and Homocysteine Calibrator 27.0 umol/L. All individual kits are packaged into individual boxes and then packaged into 1 box. Homocysteine Reagent is intended for in vitro quantitative determination of total homocysteine in serum and plasma, Recall # Z-0448-2009
CODE
a) Lot Numbers and expiration dates include L05037 2007-05, B06003 2007-08, F06011 2007-12 and H06021 200802;
b) Lot Number and expiration date include F06011 2007-12. First digit is the month of manufacture, A = Jan, B = Feb, but I is not used. Second and third digits are the year of manufacture, 05 = 2005. The remaining digits are sequential numbers for the next lot
RECALLING FIRM/MANUFACTURER
Recalling Firm: Catch, Inc., Bothell, WA, by letter on January 18, 2007.
Manufacturer: Intersect Systems, Inc., Longview, WA. Firm initiated recall is ongoing.
REASON
A high homocysteine level can be reported as falsely low.
VOLUME OF PRODUCT IN COMMERCE
2,699 kits
DISTRIBUTION
CA, PA
___________________________________
PRODUCT 
a)  Angiotech, Bone Marrow Aspiration Needle. The device is intended for use during Bone Marrow Biopsy, Recall # Z-0450-2009;

b) Angiotech, Bone Marrow Biopsy Needle. The device is intended for use during Bone Marrow Biopsy, Recall # Z-0451-2009;

c) Angiotech, T-Lok Bone Marrow Biopsy Needle. The device is intended for use during Bone Marrow Biopsy, Recall # Z-0452-2009;

d) Angiotech, Bone Marrow Harvest Needle. The device is intended for use Bone Marrow Biopsy, Recall # Z-0453-2009
CODE
a) Lot Number: 81351NDR;
b) Lot Number: 81371NGF and 81081MRM;
c) Lot Number: 81291N9Y;
d) Lot Number: 81431NHL
RECALLING FIRM/MANUFACTURER
Medical Device Technologies, Inc., Gainesville, FL, by letter on July 16, 2008. Firm initiated recall is ongoing.
REASON
Product packaging for Bone Biopsy trays/blisters may have a hole in the formed tray.
VOLUME OF PRODUCT IN COMMERCE
430 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Cytomics FC 500 Flow Cytometry System with CXP Software, Part Numbers: 626553, Version 2.2, Recall # Z-0455-2009
CODE
Version 2.2
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter on July 23, 2007.
Manufacturer: Applied Cytometry, Sheffield, UK. Firm initiated recall is complete.  
REASON
Software error: The CXP User documentation does not adequately characterize the use of the Live Gate feature.
VOLUME OF PRODUCT IN COMMERCE
565 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT 
Sinu-Lift(TM) System, LLC., Model SLS-1, Sterile, Innovative Implant Technology, The Sinu-Lift(TM) System is intended to: - Facilitate access to the maxillary sinus, - Lift the sinus membrane from the alveolar ridge of the maxilla with a minimum height of 5mm, and - Augment the space created by lifting the maxillary sinus membrane with bone graft to supplement the maxillary alveolar crest with additional height needed for anchoring an implant, Recall # Z-0505-2009
CODE
Lot number: 162-08
RECALLING FIRM/MANUFACTURER
Recalling Firm:  Innovative Implant Technology, Weston, FL, by letter dated September 30, 2008.
Manufacturer: Sequel Special Products, LLC, Waterbury, CT. Firm initiated recall is ongoing.
REASON
Possible device failure: The cutter's shaft of the Sinu-Drill of the Sinu-Lift System could potentially get stuck inside the tap, thereby not allowing the cutter to spring out of the tap upon encountering the sinus membrane, increasing the possibility of perforating the sinus membrane.
VOLUME OF PRODUCT IN COMMERCE
299 units
DISTRIBUTION
Nationwide, Canada, Mexico, Japan, Australia, Egypt, and Turkey
___________________________________
PRODUCT 
a) Compress Instrument Anchor Plug Holder, stainless steel, REF 32-481006. Non-powered, hand-held device intended for medical purposes for use with other devices in orthopedic surgery, Recall # Z-0517-2009;

b) Compress Instrument 13mm Anchor Plug Holder, stainless steel/TiAIN; REF 32-481091. Non-powered, hand-held device intended for medical purposes for use with other devices in orthopedic surgery, Recall # Z-0518-2009;

c) Compress/Finn Instrument Set Compress Anchor Plug Assembly, stainless steel; REF RD425032. Non-powered, hand-held device intended for medical purposes for use with other devices in orthopedic surgery, Recall # Z-0519-2009;

d) Compress Short Instruments Anchor Plug Holder, 12mm, stainless steel, non-sterile; REF CP460193. Non-powered, hand-held device intended for medical purposes for use with other devices in orthopedic surgery, Z-0520-2009;

e) Compress Short Anchor Plug Holder, 13mm; REF CP461038. Non-powered, hand-held device intended for medical purposes for use with other devices in orthopedic surgery, Z-0521-2009 
CODE
a) Lots 913020 and 306010;
b) Lots: 054890, 638720, 622160, 836690, and 599490;
c) Lots: 281790, 396850, 413850, 881330, and 954810;
d) Lot: 991670;
e) Lot: 991680
RECALLING FIRM/MANUFACTURER
Biomet, Inc., Warsaw, IN, by letter dated July 18, 2008. Firm initiated recall is ongoing.
REASON
The set screw may not fully seat, which will prevent the handle from mating to the instrument during use.
VOLUME OF PRODUCT IN COMMERCE
41 units
DISTRIBUTION
Nationwide, Australia, Belgium and Finland
___________________________________
PRODUCT 
Roche ISE Internal Standard Gen.2 for use on Roche cobas c systems; Catalog no. 04522320190. Product is an in vitro diagnostic, Recall # Z-0542-2009
CODE
Lot numbers: 60258801, 60258601, 60145701, 60145601, 69921901, 69921801, 69786201, 69922001, 69786101, 69676101, 69509701, 69431901, 69357601, 69342001, 69246501, 68966601 and 68871601
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics, Corp., Indianapolis, IN, by letter dated September 15, 2008.
Manufacturer: Roche Diagnostics Gmbh, Mannheim, Germany. Firm initiated recall is ongoing.
REASON
Test results, low: Sodium, potassium and chloride results on the cobas 6000 ISE unit may exhibit a downward drift in controls and patient samples within the recommended calibration interval of 24 hours.
VOLUME OF PRODUCT IN COMMERCE
7,909 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Triathlon Total Knee system Primary Tibial Baseplate #5 Beaded wPA; Catalog Number 5526-B-500, Cementless use only. Sterile. Made in Ireland. The Triathlon Total Knee System is intended for use in primary and revision total knee arthroplasty to alleviate pain and restore function, Recall # Z-0579-2009
CODE
Lot Code: SANMH
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters on September 20, 2006.
Manufacturer: Howmedica International S de RL, Limerick, Ireland. Firm initiated recall is complete.
REASON
One lot of the Triathlon Primary Beaded PA Baseplate Size 5 may not have the Peri-Apatite coating.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
PA, GA, AL, WI, UT, and OR
___________________________________
PRODUCT 
a) Synergy Pulse, Powered Flotation Therapy bed, Model number 5609. Designed to provide enhanced static and pulsation pressure relieving therapies. Provides sixteen pressure zones for customizing the support surface to each patient, and is capable of providing pulsation therapy, Recall # Z-0600-2009;

b) Synergy Dynamic, Powered Patient Rotation Bed, Model number 5607. Designed to provide enhanced static, pulsation and rotational pressure relieving therapies. Provides sixteen pressure zones for customizing the support surface to each patient, and is capable of providing alternating pressure therapy and lateral rotation up to 45 degrees side to side, Recall # Z-0601-2009;

c) Synergy Air Squared, Alternating Pressure Air Flotation Mattress, Model number 6361. Designed to prevent and treat decubitus ulcers. This is accomplished by achieving interface pressures well below capillary closure during the alternation cycle, Recall # Z-0602-2009;

d) Pro 2000, Alternating Pressure Air Flotation Mattress, Model number 5613 Designed to provide enhanced static and pulsation pressure relieving therapies, Recall # Z-0603-2009
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Hill-Rom Manufacturing, Inc., Charleston, SC, by letter on or about October 31, 2008. Firm initiated recall is ongoing.
REASON
The devices have the potential to overheat.
VOLUME OF PRODUCT IN COMMERCE
2,083 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Hitachi CXR4 Computed Tomography Scanner. This product is an x-ray imaging device that produces cross-sectional images of he body at different angles. The system reconstructs, processes, displays, and stores the collected images. The device output can provide an aid to diagnosis when used by a qualified physician and is intended for general purpose CT applications, Recall # Z-0608-2009
CODE
Serial #: CXR46202- CXR46248 (not inclusive)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hitachi Medical Systems America Inc., Twinsburg, OH, by letters on November 5, 2008.
Manufacturer: Hitachi Medical Corp., Tokyo, Japan. Firm initiated recall is ongoing.
REASON
Software error: The device has a software error that can result in a condition where the displayed image orientation does not match the display orientation markers (right-left reversal).
VOLUME OF PRODUCT IN COMMERCE
42 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
ACIST CVi Angiographic Injection System with Interface Cable for Toshiba Infinix-i cardiovascular X-ray system, Model: CVi Toshiba interface Cable, Part Number 700318-002. The ACIST injection system is an angiographic injection system used in interventional cardiology, radiology, and vascular surgical procedures. The ACIST injection system supplies radiopaque contrast media to a catheter at a user-determined variable flow rate and volume which can be instantaneously and continuously varied. The ACIST CVi injection system is able to synchronize with certain X-ray imaging systems from Siemens, Toshiba, GE and Philips. Intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures, Recall # Z-0643-2009
CODE
Not associated with specific serial or lot numbers.
RECALLING FIRM/MANUFACTURER
Acist Medical Systems, Eden Prairie, MN, by letter dated November 10, 2008. Firm initiated recall is ongoing.
REASON
Multiple Injections may result. It has been determined that when using the ACIST CVi Angiographic Injection system to synchronize with the Toshiba Infinix -i cardiovascular x-ray system there is an injection scenario that may result in multiple injections of contract media when one injection was intended.
VOLUME OF PRODUCT IN COMMERCE
18 units
DISTRIBUTION
Nationwide, France, Germany, Italy, Japan, and Spain
___________________________________
PRODUCT 
CT syngo Dual Energy Viewer on the syngo Multimodality Work Place (MMWP) and on the CT workplace, Model number 10094833. Picture Archiving and Communications System, Recall # Z-0647-2009
CODE
Software versions: syngo MMW 2007C, syngo MMWP 2008A, syngo MMWP 2008B, syngo MMWP 2008C, syngo CT 2007A, and syngo CT 2008G
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter dated October 8, 2008.
Manufacturer: Siemens AG, Medical Solution, Forchheim, Germany. Firm initiated recall is ongoing.
REASON
Indicated orientation does not match actual orientation of the patient.
VOLUME OF PRODUCT IN COMMERCE
374 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
High-low:x frame for the x:panda mechanical chair, Recall # Z-0651-2009
CODE
Article numbers 8911605-02, 8911605-02E, 8911606-02, 8911615-02, 8911615-02E and 8911616-02. Manufactured between 8/24/2007 and 10/3/2008
RECALLING FIRM/MANUFACTURER
Recalling Firm: Snug Seat, Inc., Stallings, NC, by letter dated November 6, 2008 and by visit on November 18, 2008.
Manufacturer: R82 A/S, Gedved, Denmark. Firm initiated recall is ongoing.
REASON
Breakage in the welds was discovered in a section of the chair frame.
VOLUME OF PRODUCT IN COMMERCE
67 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Measles IgG Enzyme Immunoassay Test Kit, DIAMEDIX. The assay is intended for the semi-quantitation of human IgG antibodies to measles virus in human serum by indirect immunoassay to aid in the assessment of the patient's immunological response to measles virus, to determine the immune status of individuals and, when evaluating paired sera, as an aid in the diagnosis of measles infection, Recall # Z-0607-2009
CODE
Lot numbers: 41108 and 41108B
RECALLING FIRM/MANUFACTURER
Diamedix Corp., Miami, FL, by letter on October 10, 2008. Firm initiated recall is ongoing.
REASON
Possible false-negative test results
VOLUME OF PRODUCT IN COMMERCE
974 Test Kits
DISTRIBUTION
Nationwide and England
___________________________________
PRODUCT 
Zimmer Natural-Knee II System Modular Cemented Tibial Baseplate, Right, Size 3, For cemented use only, sterile; REF 6420-01-230. The modular cemented tibial baseplate is indicated for cemented use only in skeletally mature individuals with conditions of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD), correctable valgus-varus deformity and moderate flexion contracture, or failed previous surgery where pain, deformity or dysfunction persists. When the primary or N-K II Constrained Knee System components are used, the medial and collateral ligaments must be intact. These are single use implantable devices sold sterile, Recall # Z-0871-2009
CODE
Lot number: 60830979
RECALLING FIRM/MANUFACTURER
Zimmer, Inc., Warsaw, IN, by letter dated November 25, 2008. Firm initiated recall is ongoing.
REASON
Sterility compromised: Lack of assurance of sterility, as a corner flap of the sterile barrier packaging on the inner cavity may be trapped in the seal of the barrier packaging for the outer cavity and the seal integrity of the outer sterile barrier cannot be assured.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
Nationwide

END OF ENFORCEMENT REPORT FOR JANUARY 14, 2009

 

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