—#128575

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.

FDA product code: JCF — Lymphocyte Separation Medium
Device class: Class 1
Medical specialty: Hematology
510(k) numbers: K891407, K911731
Affected lot / code info: 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

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

BD issued an "Urgent Voluntary Product Recall" Letter dated July 3, 2014 and a "Notice of Return" Form to all affected customers.

Recalling firm

Firm: Becton Dickinson & Company
Address: 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

Distribution pattern: US and Foreign

Timeline

Recall initiated: 2014-07-03
Posted by FDA: 2014-08-22
Terminated: 2016-05-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #128575. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.