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U.S. Department of Health and Human Services

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Enforcement Report for January 10, 2007

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 10, 2007
07-02

 

RECALLS AND FIELD CORRECTIONS: FOOD and COSMETICS -- CLASS I

______________________________
PRODUCT
7-Eleven Smoked Turkey & Jack Cheese on Cracked Wheat Bread with Southwest Mayonnaise in 8.4 oz, clear, flexible plastic packaging, Recall # F-084-7
CODE
Handmade On Wednesday 1011 and Handmade On Thursday 1012
RECALLING FIRM/MANUFACTURER
Fresh Grill Foods, LLC, Santa Ana, CA, by telephone and follow-up email on October 12, 2006 and press release on November 22, 2006. Firm initiated recall is ongoing.
REASON
The product contains undeclared anchovies (a sub-ingredient of the dressing used in making the sandwiches).
VOLUME OF PRODUCT IN COMMERCE
1,960/8.4 oz. sandwiches
DISTRIBUTION
CA

RECALLS AND FIELD CORRECTIONS: FOOD and COSMETICS -- CLASS II

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PRODUCT
Carnival Crunch, 0.75 oz.; UPC #76500 72132, Item #7213215, SCC, Recall # F-086-7
CODE
Code #100-76500-72132-2.
RECALLING FIRM/MANUFACTURER
Franklin Connections LP, El Paso, TX, by letter November 3, 2006. Firm initiated recall is ongoing.
REASON
Snack mix was mislabeled as "gluten-free" when it contained wheat flour, which was listed as an ingredient.
VOLUME OF PRODUCT IN COMMERCE
6,642 cases
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Spearmint Flavor, Spray Dried, Recall # F-087-7
CODE
Lot number: 70280013
RECALLING FIRM/MANUFACTURER
Todd, A.M., Co., Kalamazoo, MI, by email and telephone, on or about August 29, 2006. Firm initiated recall is ongoing.
REASON
Spearmint flavoring contains wire fragments.
VOLUME OF PRODUCT IN COMMERCE
10,750 pounds
DISTRIBUTION
IL, and Internationally

RECALLS AND FIELD CORRECTIONS: FOOD and COSMETICS -- CLASS III

______________________________
PRODUCT
Genesis Today Goji 100 Liquid Dietary Supplement 4 oz. and 32 oz. bottles; UPC Code 83448 00060 (4oz.) and 83448 00056 (32oz.), Recall # F-085-7
CODE
Lot number: 0234F6 (4 oz.), Lot number: 0228F6 (32 oz.) and Lot number: 0273D6 (32 oz.)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Genesis Today, Inc., Austin, TX, by telephone on October 16, 2006. and letter on October 25, 2006.
Manufacturer: Celmark Hydroceuticals, Orlando, FL. Firm initiated recall is ongoing.
REASON
Product contains undeclared Sulfites.
VOLUME OF PRODUCT IN COMMERCE
17,292 bottles
DISTRIBUTION
FL, NC, PA, VA, and Canada

 RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

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PRODUCT
Ranitidine HCl Tablets, USP 150 mg packaged in a blister card of 30 tablets, NDC 66689-014-01, Recall # D-424-7
CODE
Lot number: 602570
RECALLING FIRM/MANUFACTURER
Recalling Firm: Vista Pharm, Inc., Largo, FL, by telephone and letter on October 24, 2006.
Manufacturer: Wockhardt USA, Inc., Warwick, NY. Firm initiated recall is ongoing.
REASON
Failed Impurity Specification.
VOLUME OF PRODUCT IN COMMERCE
4,80 tablets
DISTRIBUTION
AZ and NC

 RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I

______________________________
PRODUCT
a) One Touch Basic/Profile and
b) One Touch Ultra- Blood Glucose Test Strips, Recall # Z-0266-2007
CODE
a) Lot numbers: 2606340, 2619932, 272894A, 2615211;
b) One Touch Ultra Lot numbers: 2691191, 2691261
RECALLING FIRM/MANUFACTURER
Core Care Technologies, Inc., Sewell NJ, by telephone beginning on October 14, 2006 and by letter on November 21, 2006. Firm initiated recall is ongoing.
REASON
Counterfeit product.
VOLUME OF PRODUCT IN COMMERCE
24,731 boxes
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

______________________________
PRODUCT
a) Allura X-per FD 10/10 x-ray, and fluoroscopy, Recall # Z-0165-2007;
b) Allura Xper FD 20/10 x-ray, and fluoroscopy, Recall # Z-0166-2007
CODE
a) Units: 127, 113, 117, 112, 131, 128, 90, 17, 35, 137, 93, 51, 95,
27, 6, 47, 98, 22, 49, 39, 103, 120, 21, 40, 70, 101, 69, 94, 89,
23, 33, 31, 30, 29, 28, 32, 100, 63, 61 Additional units are identified
with site numbers: 533397, 531926, 104950, 104953, 103283,
103281, 530653, 104497;
b) Units: 82, 33, 73, 24, 36, 71, 34, 52, 18, 19, 56, 67, 32, 22, 23, 54, 74, 69, 38
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems North America Co. Phillips, Bothell, WA, by letters on October 12, 2006 and December 11, 2006.
Manufacturer: Philips Medical Systems Nederlands, Best, Netherlands. Firm initiated recall is ongoing.
REASON
Potential for generator to lock-up. Fluoroscopy and x-ray is no longer possible, and system must be restarted to be able to continue.
VOLUME OF PRODUCT IN COMMERCE
66 devices
DISTRIBUTION
Nationwide

______________________________
PRODUCT
a) Terumo Advanced Perfusion System 1, 6 inch diameter
Roller Pump; Model 801041, Recall # Z-0292-2007;
b) Terumo Advanced Perfusion System 1, 4 inch diameter
Roller Pump; Model 801040, Recall # Z-0293-2007
CODE
a) Serial numbers: 0976 and 0979;
b) Serial number 3091 (correct) was labeled as serial number 0391 (incorrect).
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by in-house servicing on October 6, 2005 and October 18, 2006. Firm initiated recall is complete.
REASON
a) Six inch roller pumps were mislabeled as 4 inch roller pumps;
b) An incorrect serial number was placed on one roller pump
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
HeartStart FR2+ Defibrillator, Recall # Z-0308-2007
CODE
Serial Numbers affected: 1204137082, 1204137014, 1204137016, 1204137022, 1204137126, 1204137128, 1204137132, 1204137136, 1204137146, 1204137018, 1204137020, 1204137124, 1204137130, 1204137134, 1204137138, 1204137028, 1204137030, 1204137032, 1204137036, 1204137038, 1204137040, 1204137042, 1204137044, 1204137046, 1204137048, 1204137050, 1204137064, 1204137070, 1204137072, 1204137074, 1204137076, 1204137078, 1204137080, 1204137084, 1204137086, 1204137088, 1204137090, 1204137092, 1204137094, 1204137140, 1204137162, 1204137164, 1204137166, 1204137168, 1204137196, 1204137198, 1204137200, 1204137202, 1204137204, 1204137206, 1204137208, 1204137034, 1204137144, 1204137142, 1204137228, 1204137396, 1204137054, 1204137056, 1204137058, 1204137060, 1204137062, 1204137066, 1204137068, 1204137096, 1204137100, 1204137102, 1204137104, 1204137106, 1204137108, 1204137110, 1204137112, 1204137114, 1204137116, 1204137118, 1204137226, 1204137230, 1204137238, 1204137266, 1204137268, 1204137270, 1204137272, 1204137286, 1204137290, 1204137294, 1204137120, 1204137122, 1204137224, 1204137232, 1204137234, 1204137236, 1204137274, 1204137276, 1204137280, 1204137282, 1204137284, 1204137288, 1204137292, 1204137296, 1204137298, 1204137300, 1204137304, 1204137306, 1204137308, 1204137312, 1204137316, 1204137318, 1204137322, 1204137324, 1204137330, 1204137354, 1204137388, 1204137394, 1204137572, 1204137352, 1204137386, 1204137382, 1204137384, 1204137472, 1204137483, 1204137381, 1204137302, 1204137310, 1204137314, 1204137334, 1204137336, 1204137338, 1204137340, 1204137342, 1204137344, 1204137346, 1204137356, 1204137358, 1204137360, 1204137362, 1204137364, 1204137374, 1204137376, 1204137379, 1204137389, 1204137390, 1204137392, 1204137398, 1204137400, 1204137402, 1204137403, 1204137404, 1204137406, 1204137408, 1204137409, 1204137410, 1204137411, 1204137412, 1204137414, 1204137416, 1204137418, 1204137420, 1204137421, 1204137424, 1204137427, 1204137429, 1204137433, 1204137435, 1204137438, 1204137442, 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1204137380, 1204137425, 1204137697, 1204137540, 1204137637, 1204137680, 1204137610, 1204137659, 1204137800, 1204137702, 1204137634, 1204137513, 1204137515, 1204137517, 1204137519, 1204137521, 1204137523, 1204137542, 1204137544, 1204137546, 1204137560, 1204137562, 1204137563, 1204137565, 1204137566, 1204137567, 1204137569, 1204137571, 1204137573, 1204137574, 1204137575, 1204137581, 1204137583, 1204137584, 1204137587, 1204137588, 1204137589, 1204137590, 1204137591, 1204137592, 1204137593, 1204137594, 1204137595, 1204137597, 1204137598, 1204137599, 1204137600, 1204137602, 1204137603, 1204137604, 1204137605, 1204137606, 1204137607, 1204137608, 1204137609, 1204137611, 1204137612, 1204137613, 1204137614, 1204137616, 1204137618, 1204137624, 1204137626, 1204137628, 1204137630, 1204137632, 1204137636, 1204137638, 1204137640, 1204137641, 1204137642, 1204137644, 1204137645, 1204137646, 1204137647, 1204137648, 1204137649, 1204137650, 1204137652, 1204137654, 1204137655, 1204137656, 1204137658, 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1204137796, 1204137798, 1204137802, 1204137804, 1204137806, 1204137808, 1204137810, 1204137812, 1204137814, 1204137816, 1204137818, 1204137820, 1204137822, 1204137824, 1204137828, 1204137830, 1204137832, 1204137842, 1204137852, 1204137854, 1204137788, 1204137617, 1204137665, 1204137596, 1204137786, 1204137840, 1204138056, 1204137954, 1204138004, 1204137865, 1204137911, 1204137831, 1204137787, 1204137825, 1204137861, 1204137863, 1204137875, 1204137877, 1204137879, 1204137883, 1204137887, 1204137889, 1204137891, 1204137897, 1204137901, 1204137905, 1204137907, 1204137909, 1204137913, 1204137915, 1204137917, 1204137919, 1204137937, 1204137939, 1204137943, 1204137950, 1204137952, 1204137956, 1204137957, 1204137968, 1204137976, 1204137984, 1204137986, 1204137992, 1204138000, 1204138002, 1204138006, 1204138008, 1204138010, 1204138012, 1204138016, 1204138048, 1204137757, 1204137766, 1204137827, 1204137867, 1204137881, 1204137885, 1204137893, 1204137899, 1204137903, 1204137925, 1204137940, 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RECALLING FIRM/MANUFACTURER
Phillips Medical Systems, Seattle, WA, by letters on December 19, 2006. Firm initiated recall is ongoing.
REASON
Potential for shock treatment to be delayed or prevented due to board contamination that causes intermittent switch operation.
VOLUME OF PRODUCT IN COMMERCE
2,000 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
a) Terumo Advanced Perfusion System 1; 100V -120V, 15 A
(circuit breaker), 50/60 Hz (20A power source required) base;
Model 801763, Recall # Z-0322-2007;
b) Terumo Advanced Perfusion System 1; 220V -240V, 7A
(circuit breaker), 50/60 Hz (10A power source required) base;
Model 801764. (Not distributed within the United States),
Recall # Z-0323-2007;
c) Terumo Advanced Perfusion System 1, 4 inch diameter
Roller Pump; Model 801040, Recall # Z-0324-2007;
d) Terumo Advanced Perfusion System 1, 6 inch diameter
Roller Pump; Model 801041, Recall # Z-0325-2007;
e) Terumo Advanced Perfusion System 1 Air Bubble
Detection Module; Catalog number 802110,
Recall # Z-0326-2007;
f) Terumo Advanced Perfusion System 1 Data Interface
CDI 100; Catalog number 802558, Recall # Z-0327-2007;
g) Terumo Advanced Perfusion System 1 Data Interface
CDI 500; Catalog number 803479, Recall # Z-0328-2007;
h) Terumo Advanced Perfusion System 1 Venous Occluder;
Catalog number 803480, Recall # Z-0329-2007;
i) Terumo Advanced Perfusion System 1 Level Detection;
Catalog number 802111, Recall # Z-0330-2007;
j) Terumo Advanced Perfusion System 1 Pressure Monitoring;
Catalog number 802112; Recall # Z-0331-2007;
k) Terumo Advanced Perfusion System 1 Temperature Monitoring
System; Catalog number 802114; Recall # Z-0332-2007;
l) Terumo Advanced Perfusion System 1 Flow Module;
Catalog number 802018, Recall # Z-0333-2007;
m) Terumo Advanced Perfusion System 1 Data Interface RS 485;
Catalog number 803518, Recall # Z-0334-2007;
n) Terumo Advanced Perfusion System 1 Control Unit;
Catalog number 801046, Recall # Z-0335-2007;
o) Terumo Advanced Perfusion System 1 Electronic
Oxygen Blender/analyzer; Catalog number 801188,
Recall # Z-0336-2007
p) Advanced Perfusion System 1 Central Control Monitor;
Catalog number 802100, Recall # Z-0337-2007
CODE
a) Serial numbers: 0013, 0017, 0019 through 0039,
1141 through 0163, 0165 through 0200 and 0203 through 0244;
b) Serial numbers 0006 through 0066, 0100 through 0116,
0118 and 0119;
c) Serial numbers: 0031, 0032, 0034 through 0041, 0045,
0047 through 0050, 0052, 0054, 0056 through 0059,
0064, 0067, 0071 through 0073, 0075 through 0080,
0082 through 0086, 0088 through 0095, 0097 through 0099,
0101 through 0105, 0107, 0108, 0110, 0111, 0113 through
0135, 0137 through 0140, 0142 through 0165, 0167 through
0180, 0182 through 0191, 0194, 0195, 0197 through 0204,
0206, 0207, 0209, 0211 through 0235, 0237 through 0250,
0252 through 0291, 0293 through 0437, 0440 through 0522,
0524 through 0527, 0700 through 0725, 0727, 0730 through
0858, 0860 through 0878, 0880, 0881, 0885 through 0903,
0906 through 0912, 0922 and 0924;
d) Serial numbers: 0033, 0034, 0036, 0038, 0041 through 0043,
0045, 0047 through 0049, 0052, 0054, 0055, 0057, 0058,
0061, 0063, 0064, 0069, 0072, 0075 through 0096, 0098,
0099, 0102 through 0116, 0118, 0124, 0127 through 0136,
0138 through 0146, 0148 through 0151, 0153 through 0163,
0165 through 0170, 0172, 0173, 0175, 0179, 0181 through 0187,
0189 through 0200, 0202 through 0231, 0233 through 0240,
0242 through 0278, 0281 through 0302, 0304 through 0481,
0483 through 0587, 0700 through 0753, 0757, 0758, 0760
through 0769, 0771 through 0787, 0789 through 0793,
0795 through 0866, 0868 through 0898, 0900 through 0921,
0923 through 0978, 0980 through 1001, 1004 through 1015,
1017, 1019 and 1024 through 1027;
e) Serial numbers: 00023 through 00026, 00034, 00041, 00051,
00060, 00063 through 00065, 00067 through 00069, 00071
through 00089, 00091 through 00139, 00141 through 00242,
00246 through 00280, 00282 through 00297, 00299 through
00323, 00325 through 00410 and 00419;
f) Serial numbers: 00008 through 00011, 00013, 00020 through
00030, 00032 through 00034, 00036 through 00059 and
00061 through 00078;
g) Serial numbers: 00009 through 00012, 00014 through 00017,
00019, 00023 through 00037, 00039 through 00049, 00051
through 00119, 00121, 00122 and 00124 through 00149;
h) Serial numbers: 00012 through 00019, 00021, 00025,
00027 through 00031, 00033 through 00053, 00055 through
00066, 00068 through 00075, 00078 through 00139, 00141
through 00147, 00149 through 00157 and 00159 through 00213;
i) Serial numbers: 00023, 00025 through 00027, 00055, 00061 through
00081, 00083 through 00099, 00101 through 00109, 00111 through
00183, 00185 through 00260, 00262 through 00269. 00271 through
00293, 00295 through 00307 and 00309 through 00357;
j) Serial numbers: 00017 through 00032, 00036, 00043, 00045
through 00057, 00059 through 00062, 00065 through
00071, 00073 through 00079, 00081 through 00099,
00102 through 00122, 00125 through 000251, 00253
through 00292, 00296 through 00309, 00311 through 00349,
00352 through 00479, 00484 and 00489;
k) Serial numbers: 00019 through 00034, 00036, 00037, 00046
through 00053, 00055 through 00069, 00073 through 00114,
00116 through 00128, 00131 through 00193, 00195 through 00203,
00205 through 00334, 00339 through 00355, 00357 through 00414,
00416 through 00431. 00434, 00435, 00439 through 00447, 00448
through 00466, 00468 through 00473, 00475 through 00477, 00479
through 00582, 00584 through 00590, 00592 through 00594 and 00606;
l) Serial numbers: 00017, 00020, 00023 through 00026, 00029 through
00031, 00033, 00034, 00036 through 00048, 00051 through 00055,
00057 through 00078, 00080 through 00120, 00122 through 00134,
00136, 00138 through 00155, 00158 through 00169, 00171 through
00210, 00212 through 00243 and 00248;
m) Serial numbers: 00007 through 00014, 00016 through 00024 and
00026 through 00031;
n) Serial numbers: 0020 through 0025, 0030 through 0036, 0038
through 0040, 0042, 0044, 0045, 0047 through 0081, 0083, 0084,
0086 through 0102, 0106 through 0110, 0112 through 0130, 0132
through 0137, 0139 through 0147, 0149 through 0154, 0157 through
0166, 0169 through 0175 and 0177 through 0189;
o) Serial numbers: 00010 through 00016, 00019, 00024 through 00027,
00030 through 00033, 00035, 00036, 00038 through 00040, 00042
through 00046, 00048 through 00050, 00052 through 00054, 00056
through 00059, 00061 through 00063, 00065, 00066, 00068, 00069,
00071 through 00073, 00075 through 00078, 00082, 00084, 00085,
00087, 00088, 00091, 00094, 00095, 00098 through 00103, 00105
through 00107, 00109 through 00111, 00113 through 00115, 00122,
00126 through 00129, 00133 through 00135, 00139, 00140, 00144,
00145, 00147, 00148, 00151, 00152, 00154 through 00157, 00163,
00167, 00168 through 00174, 00176 through 00182, 00184 through
00196, 00200, 00202 through 00206, 00210, 00211, 00213, 00214,
00216 through 00224, 00228 through 00231, 00237 through 00241,
00245 through 00250, 00300 through 00327 and 00330;
p) Serial numbers: 0047, 0049, 0052, 0054, 0055, 0065, 0066, 0069,
0071, 0072, 0074, 0076 through 0088, 0090 through 0111, 0113
through 0131, 0133 through 0276, 0278 through 0288, 0291
through 0293, 0295 through 0301 and 0303 through 0350
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems Corp., Ann Arbor, MI, sent an addendum to the operators manual on October 12, 2004 and December 15, 2004. Firm initiated recall is ongoing.
REASON
Device module(s) may fail to properly initialize during start up, thus resulting in that single module being inoperable and a red 'X' being displayed on the monitor screen.
VOLUME OF PRODUCT IN COMMERCE
4,740 devices
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
Product Description: Edwards Lifesciences-Swan-Ganz,Thermodilution Venous Infusion Port (VIP) Catheter with AMC Thromboshield (An Antimicrobial*Heparin Coating), REF:831HF75, Model Number: 831FH75, Recall # Z-0338-2007
CODE
Lot number: 246HC197 Expiration Date: Feb. 2008
RECALLING FIRM/MANUFACTURER
Edwards LifeSciences Technology SAEL, Anasco, PR, by letter on November 28, 2006. Firm initiated recall is ongoing.
REASON
Misbranding-One lot of Swan-Ganz Thermodilution VIP Catheters, Model 831HF75, lot 246HC197 was labeled with different model information (831F75) on the edge label . The edge label states the model is 831F75 which incorrectly indicates that product does NOT contain an antimicrobial heparin coating. (The tray lid label correctly states the model is 831HF75, containing the heparin coating).
VOLUME OF PRODUCT IN COMMERCE
1,110 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
Bivona Adult Tracheostomy Tube, I.D. 8.5 mm, O.D 11.0 mm, Length 88 mm, TTS 11.8 mm, Mfrd by Smiths Medical Critical Care; Product code 670185, Recall # Z-0339-2007
CODE
Lot numbers 1008187, 1023402 and 1012767
RECALLING FIRM/MANUFACTURER
Smiths Medical ASD, Inc., Gary, IN, by letter dated August 25, 2006. Firm initiated recall is ongoing.
REASON
Mislabeled- The outer diameter (OD) of the shaft is labeled as 11.0 m on the inner, outer and tray label in error. The OD is actually 11.8 mm.
VOLUME OF PRODUCT IN COMMERCE
197 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
a) TruFit CB Plug Size Code Red, 7mm; quantity 1;
Part #605-001-03; product labeled as sterile;
Recall # Z-0440-2007;
b)TruFit CB Plug Size Code Blue, 9mm; quantity 1;
Part #605-001-05; product labeled as sterile;
Recall # Z-0441-2007;
c) TruFit BGS Plug Size Code Red, 7mm; quantity 1;
Part #600-001-03; product labeled as sterile;
Recall # Z-0442-2007;
d) TruFit BGS Plug Size Code Blue, 9mm; quantity 1;
Part #600-001-05; product labeled as sterile;
Recall # Z-0443-2007
CODE
051024-14 and 011-051024-14
RECALLING FIRM/MANUFACTURER
Recalling Firm: Smith & Nephew, Inc., Endoscopy Division, Andover, MA, by letter on September 29, 2006.
Manufacturer: OsteoBiologics, Inc., San Antonio, TX. Firm initiated recall is ongoing.
REASON
Mis-packaging. Product in the package may be a different size than indicated on the labeling.
VOLUME OF PRODUCT IN COMMERCE
119 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Puritan Bennett KnightStar 330 Bi-Level Ventilator, Catalogue Numbers: Y-KS330-NA, Y-KS330-SD, DSY-KS330-NA, DSY-K5330-SD, DLY-KS330-NA & DLY-KS330-SD, Recall # Z-0444-2007
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puritan Bennett Corporation, Carlsbad, CA, by letter on August 31, 2006.
Manufacturer: Nellcor Puritan Bennett Ireland, Galway, Ireland. Firm initiated recall is ongoing.
REASON
Directions for Use-Puritan Bennett has determined that a service interval should be defined for the device. The firm has also determined that an exhalation filter should be employed when the device is in use.
VOLUME OF PRODUCT IN COMMERCE
7,754 devices
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
a) Bayer Advia 70 Hematology Analyzer, Recall # Z-0448-2007;
b) Drew Excell 22 Hematology Analyzer, Recall # Z-0449-2007
CODE
All lots
RECALLING FIRM/MANUFACTURER
Drew Scientific, Inc., Oxford, CT., by letter on August 24, 2006. Firm initiated recall is ongoing.
REASON
Flags and alerts on the user interface will not automatically transfer to the LIS.
VOLUME OF PRODUCT IN COMMERCE
844 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
a) Bayer Advia 70 Hematology Analyzer, Recall # Z-0450-2007;
b) Drew Excell 22 Hematology Analyzer, Recall # Z-0451-2007
CODE
All lots.
RECALLING FIRM/MANUFACTURER
Drew Scientific, Inc., Oxford, CT., by letter on September 20, 2006. Firm initiated recall is ongoing.
REASON
System has given inaccurate readings when running samples that trigger an extra rinse due to very high WBC, RBC or Platelet counts.
VOLUME OF PRODUCT IN COMMERCE
844 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
a) LifeScan brand One Touch Sure Step-Blood Glucose Monitoring
System Test Strips, 50 strips per package, part number: 020-052-01,
Recall # Z-0452-2007;
b) LifeScan brand One Touch Sure Step Pro-Blood Glucose Monitoring
System Test Strips, 50 strips per package, part number: 010-797-02,
Recall # Z-0453-2007
CODE
a) Lot number: 2627353;
b) Lot number: 2634187008
RECALLING FIRM/MANUFACTURER
LifeScan, Inc., Milpitas, CA, by letter on September 29, 2006 and posted the notice on the website. Firm initiated recall is ongoing.
REASON
Inaccurage test results: testing may lead to no test results, error message or inaccurately low test results.
VOLUME OF PRODUCT IN COMMERCE
26,398 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Phenobarbital- Reagent-Clinical Chemistry--List number: 1E08-20-Abbott Diagnostics Division, Recall # Z-0454-2007
CODE
Lot number: 39074HW00 (exp. 9/30/06),
Lot number: 41008HW00 (exp. 10/31/06),
Lot number: 42063HW00 (exp. 12/31/06)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Laboratories, Inc., South Pasadena, CA, by letters on September 26, 2006.
Manufacturer: Dade Behring, Inc., Cupertino, CA. Firm initiated recall is ongoing.
REASON
Erratic elevated results and or the inability to calibrate due to imprecision.
VOLUME OF PRODUCT IN COMMERCE
448 kits
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
BOLD/INI-CLIP 2.2mm Drill Bit with AO Attachment. Model/Catalog number: 159004ND, Recall # Z-0466-2007
CODE
Lot Numbers: D2CJ/; D2CJ/1; D2PS; E0X4; E14K; E14L; E14M; E14N; E1KM; E1KN; E1X2; E24S; E2JS; E2LP
RECALLING FIRM/MANUFACTURER
Recalling Firm: Integra LifeSciences, Corp., Plainsboro, NJ, by letter, telephone and e-mail on November 10, 2006.
Manufacturer: NewDeal SA, Lyon, France. Firm initiated recall is ongoing.
REASON
Incorrect drill length-Cannulated drill bits were manufactured to incorrect specifications (shorter length) resulting in inadequate preparation of bone prior to insertion of the UNI-CLIP Staple.
VOLUME OF PRODUCT IN COMMERCE
107 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Expo32 ADC Software Version 1.1C, Part Number 6418337-New Users Software Kit, and Part Number 175454 Upgrade Software Kit used with the Coulter EPICS XL Flow Cytometers, Recall # Z-0471-2007
CODE
Version 1.1C
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter, Inc., Brea, CA, by letter on November 1, 2006.
Manufacturer: Applied Cytometry, Sheffied, UK. Firm initiated recall is ongoing.
REASON
The firm has confirmed that the ratio parameter assignments (numerator and denominator) of a protocol may inadvertently change after the Parameter Selection Dialog box is accessed. This issue is limited to only protocols utilizing the Ratio parameter.
VOLUME OF PRODUCT IN COMMERCE
28 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

______________________________
PRODUCT
a) RYM-5000 InVision-Plus® Neutral Displacement I.V. Connector,
packaged 200 units per box, 5 boxes per case (1000 units/case);
labeled as Sterile-Nonpyrogenic; assembled in Mexico,
Recall # Z-0319-2007;
b) RYM-5000 InVision-Plus® NEUTRAL™ I.V. Connector,
packaged 200 units per box, 5 boxes per case (1000 units/case);
abeled as Sterile-Nonpyrogenic; assembled in Mexico,
Recall # Z-0320-2007;
c) RYM-5001 InVision-Plus® Neutral Displacement I.V. Connector,
packaged 100 units per box, 5 boxes per case (500 units/case);
labeled as Sterile-Nonpyrogenic; assembled in Mexico,
Recall # Z-0320-2007
CODE
a) Lot numbers: 400, 401, and 402;
b) Lot number: 405;
c) Lot numbers: 500, 502, 503, 504, and 505
RECALLING FIRM/MANUFACTURER
Recalling Firm: Rymed Technologies, Inc., Austin, TX, by email and telephone on May 25, 2006.
Manufacturer: Accelent Juarez, Juarez, Mexico. Firm initiated recall is ongoing.
REASON
Weld failures on IV connector (area of female luer and spike body).
VOLUME OF PRODUCT IN COMMERCE
79,328 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
a) Confirm Clearly Smart Pregnancy Test (Confirm Clearly Starter Kits, UPC Code 3-02340-30136-7, Product Code 30136; Confirm Clearly Starter Kits: When sold in the U.S., the product consists of a reader and two disposable test sticks; when sold in Canada, the product consists of a reader and one disposable test stick;
b) Confirm Clearly Refills Kits, UPC Code 3-02340-30138-1, Product Code 30138) Note: Confirm Clearly Refills Kits: The refill consists of three disposable test sticks;
c) Special Pack Deal (6 Starter Kits & 6 Refill Kits), Recall # Z-0469-2007
CODE
a) Lot numbers : LE612, LE613, LF601, LF606, LF612, LG604, LG609, LG616, LH601, LH607, LH610, LH615, LH621, LJ607, LK605 & LK611;
b) Lot numbers : LE611, LF603, LF611, LG602, LG605, LG613, LG614, LH602, LH603, LH611, LH612, LH614, LH619, LJ606, LK602 & LK610;
c) Lot number; LH608
RECALLING FIRM/MANUFACTURER
Mizuho USA, Inc., Poway, CA, by telephone on November 14, 2006 and by letters on November 21, 2006. Firm initiated recall is ongoing.
REASON
False positives-the firm has received a higher than expected rate of complaints regarding false-positive results.
VOLUME OF PRODUCT IN COMMERCE
241,200 Starter Kits and 232,800 Refill Kits
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS I

______________________________
PRODUCT
WSI Pride Feeds Horse Mineral Developer.. Net wt. 50 lbs... Feeding instructions: Foals & Ponies: add 2 to 3 ounces per day to regular grain rations for foals and ponies. Mature Horses: Add 4 to 5 ounces per day to regular grain rations for mature horses. Recall # V-002-2007
CODE
7739-052206 first four numbers are the batch numbers, last six are date of production
RECALLING FIRM/MANUFACTURER
Western Stockmen, Caldwell, ID, by telephone on July 24, 2006 and letter on November 7, 2006. Firm initiated recall is complete.
REASON
Product contains undeclared Monensin/Rumensin
VOLUME OF PRODUCT IN COMMERCE
44/50 lb. bags
DISTRIBUTION
OR

______________________________
PRODUCT
Non-medicated horse feed -- “Hoof & Coat for Horses” sold in bulk (1.19 tons), Recall # V-003-2007
CODE
44570
RECALLING FIRM/MANUFACTURER
Western Stockmen, Caldwell, ID, by telephone on November 7, 2006. Firm initiated recall is complete.
REASON
Product contains Runsensin which is toxic to horses.
VOLUME OF PRODUCT IN COMMERCE
1.19 tons
DISTRIBUTION
ID

END OF ENFORCEMENT REPORT FOR JANUARY 10, 2007

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