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 Number	Tubing Set Name	Lot Number
000777110	Dual-Needle Extended Life Platelet Set with LRS Chamber	03N0005 04NXXXXX 05NXXXXX 06NXXXXX 07N15247
70100	Dual-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
70400	Single-Needle Extended Life Platelet Set with LRS Chamber	04NXXXXX 05NXXXXX 07N15228
777003005	Dual- 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 Number	Tubing Set Name	Lot 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
777800401	Trima Accel LRS Platelet, Plasma, RBC Set	04NXXXX 05NXXXX 06NXXXX 07N9101 07N9102 08N9101
777800403	Trima Accel LRS Platelet, Plasma, RBC Set	03N3128 04NXXXX 05NXXXX 06NXXXX 07N3116
777800450	Trima Accel LRS Platelet, Plasma, RBC + TLR Filter Set	04NXXXX 005NXXXX 06NXXXX 07N3105
777800451	Trima Accel LRS Platelet, Plasma, RBC + TLR Filter Set	07N9104
777800453	Trima Accel LRS Platelet, Plasma, RBC + TLR Filter Set	03N3130 04NXXXX 05NXXXX 07N3213
80300	Trima Accel LRS Platelet, Plasma Set	03N0002 03N1003 03N1004 03N2123 04NXXXX 05NXXXX 06NXXXX 07N2110 07N2112 07N2124
80400	Trima Accel LRS Platelet, Plasma, RBC Set	03N2129 03N3124 04NXXXX 05NXXXX 06NXXXX 07N3111 07N3118 07N3123
80410	Trima Accel LRS Platelet, Plasma, RBC + Auto P.A.S. Set	05NXXX 06NXXX
80411	Trima Accel LRS Platelet, Plasma, RBC + Auto P.A.S. Set	06NXXXX
80413	Trima Accel LRS Platelet, Plasma, RBC + Auto P.A.S. Set	05NXXXX 06NXXXX
80420	Trima Accel Enhanced Platelet, Plasma, RBC + Auto P.A.S. Set	05NXXXX
80440	Trima Accel Enhanced Platelet, Plasma, RBC Set	04NXXXX 06NXXXX 07N2219 07N3109 07N3205
80449	Trima Accel Enhanced Platelet, Plasma, RBC Set	03N2119 03N2121 03N2122 03N2127 03N2128 03N2226 04NXXXX 05NXXXX 06NXXXX 07N1111 07N1116 07N1123 07N2126
80450	Trima Accel LRS Platelet, Plasma RBC + TLR Filter Set	03N3121 05NXXXX 07N3313
80460	Trima Accel PPC, Plasma, RBC + TLR Filter Set	04NXXXX 06NXXXX
80480	Trima Accel LRS Platelet, Plasma, RBC + TLR Filter + Auto P.A.S. Set	05NXXXX
80483	Trima Accel LRS Platelet, Plasma, RBC + TLR Filter+ Auto P.A.S. Set	05NXXXX
80490	Trima Accel Enhanced PPC, Plasma, RBC Set	03N3123 04NXXXX 06NXXXX 07N3113
80491	Trima 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.