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Recall Observatory FDA recall evidence

Device product

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.

Z-2542-2014

July 03, 2014

Class II

Product summary

Firm
Becton Dickinson & Company
Event
Event 68730
Status
Terminated
Classification
Class II
Quantity
296,160 tubes
Official record key
device-enforcement:Z-2542-2014

Official wording

Reason: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.