device · product 1 of 1
BD Vacutainer CPT Cell Preparation Tube with Sodium Heparin, 8 mL, 16 x 125 mm, Catalog #REF 362753, Lot #4063409 with expiry 03/2015, intended for the collection of whole blood and the separation of mononuclear cells.
- Recall number
- Z-2542-2014
- Initiated
- July 03, 2014
- Classification
- Class II
- Status
- Terminated
- Recalling firm
- Becton Dickinson & Company
- Quantity
- 296,160 tubes
App-derived interpretation
BD has initiated the recall of its Vacutainer CPT Cell Preparation Tube due to poor separation, resulting in a reduced number of recovered mononuclear cells.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Inspect official wording and provenance
Reason for recall
BD has initiated the recall of its Vacutainer CPT Cell Preparation Tube due to poor separation, resulting in a reduced number of recovered mononuclear cells.
Code information
A) REF #362753, 8 mL,16 x 125 mm, Lot #'s 4063409, 4063413 and 4063414 with expiry 03/15, Lot #'s 4090214, 4090215 and 4090216 with expiry 04/15; B) REF #362760, 4 mL, 13 x 100 mm, Lot #4063412 with expiry 03/15; C) REF #362761, 8 mL, 16 x 125 mm, Lot #'s 4063410, 4063411, 4063415, 4063416, 4063417, 4063418 and 4063419 with expiry 03/15; Lot #'s 4090230, 4090232, 4090234 and 4090237 with expiry 04/15. Outside US D) REF #362780, 8 mL, 16 x 125 mm, Lot #'s 4063420 and 4063455 with expiry 03/15; Lot #'s 4090241 and 4090242 with expiry 04/15. E) REF #362781, 4 mL, 13 x 100 mm, Lot # 4063421 with expiry 03/15 F) REF #362782, 8 mL, 16 x 125 mm, Lot #'s 4063422 and 4063423 with expiry 03/15; Lot #'s 4090244 and 4090246 with expiry 04/15
Distribution pattern
US and Foreign