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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Recall of Tubing Sets used with COBE Spectra Apheresis System, Trima and Trima Accel Automated Blood Collection Systems-Gambro BCT, Inc.

DATE RECALL INITIATED:

November 26, 2007

PRODUCT / LOT NUMBERS:
COBE Spectra Disposable Tubing Sets
Catalog NumberTubing Set NameLot Number
000777110Dual-Needle Extended Life Platelet Set with LRS Chamber

03N0005

04NXXXXX

05NXXXXX

06NXXXXX

07N15247

70100Dual-Needle Extended Life Platelet Set

04NXXXXX

05NXXXXX

07N15244

70300

Dual-Needle Extended Life Platelet Set with LRS Chamber

03N0006

04NXXXXX

05NXXXXX

06NXXXXX

07N15246

70310

Dual-Needle Extended Life Platelet Set with LRS Chamber

 

04NXXXXX

05NXXXXX

06NXXXXX

70400Single-Needle Extended Life Platelet Set with LRS Chamber

04NXXXXX

05NXXXXX

07N15228

777003005Dual- Needle Extended Life Platelet Set

04NXXXXX

05NXXXXX

777003015

Dual-Needle Extended Life Platelet Set with LRS Chamber

 

03N15290

04NXXXXX

05NXXXXX

06NXXXXX

07N15245

07N15306

777003215

Single-Needle Extended Life Platelet Set with LRS Chamber 

 

03N15288

03N15289

04NXXXXX

05NXXXXX

06NXXXXX

07N15216

Trima Automated Blood Collection Disposable Tubing Sets

Catalog NumberTubing Set NameLot Number
777800100

Trima LRS Platelet, Plasma, RBC Set with Sharps Protection

03N1130

04NXXXX

05NXXXX

06NXXXX

07N1105

777800400

Trima Accel LRS Platelet, Plasma, RBC Set

03N1116

03N1121

03N1126

03N2116

03N3116

03N3120

03N3126

03N3230

04NXXXX

05NXXXX

06NXXXX

07N1118

07N2105

07N2113

07N2116

07N2203

07N2224

07N3102

07N3112

07N3117

07N3119

07N3124

07N3126

07N3131

07N3226

07N3230

777800401Trima Accel LRS Platelet, Plasma, RBC Set

04NXXXX

05NXXXX

06NXXXX

07N9101

07N9102

08N9101

777800403Trima Accel LRS Platelet, Plasma, RBC Set

03N3128

04NXXXX

05NXXXX

06NXXXX

07N3116

777800450Trima Accel LRS Platelet, Plasma, RBC + TLR Filter Set

04NXXXX

005NXXXX

06NXXXX

07N3105

777800451Trima Accel LRS Platelet, Plasma, RBC + TLR Filter Set07N9104
777800453Trima Accel LRS Platelet, Plasma, RBC + TLR Filter Set

03N3130

04NXXXX

05NXXXX

07N3213

80300Trima Accel LRS Platelet, Plasma Set

03N0002

03N1003

03N1004

03N2123

04NXXXX

05NXXXX

06NXXXX

07N2110

07N2112

07N2124

80400Trima Accel LRS Platelet, Plasma, RBC Set

03N2129

03N3124

04NXXXX

05NXXXX

06NXXXX

07N3111

07N3118

07N3123

80410Trima Accel LRS Platelet, Plasma, RBC + Auto P.A.S. Set

05NXXX

06NXXX

80411Trima Accel LRS Platelet, Plasma, RBC + Auto P.A.S. Set06NXXXX
80413Trima Accel LRS Platelet, Plasma, RBC + Auto P.A.S. Set

05NXXXX

06NXXXX

80420Trima Accel Enhanced Platelet, Plasma, RBC + Auto P.A.S. Set05NXXXX
80440Trima Accel Enhanced Platelet, Plasma, RBC Set

04NXXXX

06NXXXX

07N2219

07N3109

07N3205

80449Trima Accel Enhanced Platelet, Plasma, RBC Set

03N2119

03N2121

03N2122

03N2127

03N2128

03N2226

04NXXXX

05NXXXX

06NXXXX

07N1111

07N1116

07N1123

07N2126

80450Trima Accel LRS Platelet, Plasma RBC + TLR Filter Set

03N3121

05NXXXX

07N3313

80460Trima Accel PPC, Plasma, RBC + TLR Filter Set

04NXXXX

06NXXXX

80480Trima Accel LRS Platelet, Plasma, RBC + TLR Filter + Auto P.A.S. Set05NXXXX
80483Trima Accel LRS Platelet, Plasma, RBC + TLR Filter+ Auto P.A.S. Set05NXXXX
80490Trima Accel Enhanced PPC, Plasma, RBC Set

03N3123

04NXXXX

06NXXXX

07N3113

80491Trima Accel Enhanced PPC, Plasma, RBC Set

03N9102

04NXXXX

06NXXXX

07N9103

MANUFACTURER:

Gambro BCT, Inc.
Lakewood, CO

REASON:

Gambro BCT is receiving a number of reports of a leak occurring near the spike port on the secondary platelet collect bag on COBE Spectra and Trima tubing sets. The secondary platelet bag does not have the Platelet Product Sampler (sample bulb). The leak is very small and occurs consistently in the same location. These leaks are observed during run as well as post collection. Not all individual sets within the affected lots contain the defect. Only those tubing sets assembled with a secondary platelet bag containing the numeric identifiers 12, 4 have potential for the defect. The identifier can be found near the spike port of the bag. Because of the infrequent occurrence of this defect and the low safety risk, you may continue to use COBE Spectra and Trima sets within the affected lots as long as you do not use kits which contain secondary platelet collect bags with the 12, 4 numeric identifiers. Prior to loading the set, identify the potentially affected secondary platelet collect bag. If any individual sets contain a suspect bag, do not use these sets. Customers are asked to contact the manufacturer to arrange for return of kits with the the suspect platelet collect bag.

 

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002