—#66592

Product

BD Vacutainer Push Button Blood collection Sets with Pre-Attached Holder; Catalog Number: 368656; 23 g X12 " PBBCS w/PAH (Preattached), BD Diagnostics, Franklin Lakes, NJ

FDA product code: JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K011984
Affected lot / code info: Lot #'s: 6090251R, 6094839, 6111757R, 6121669, 6121676, 6138669, 6146186R, 6152710, 6151443, 6160625, 6164839, 6171015, 6174156, 6178381, 7018205, 7025868, 7026017, 7033728, 7093399, 7093400, 7093403, 7106969, 7106970, 7106971, 7106972, 7113647, 7113648, 7124156, 7124157, 7131786, 7141678, 7141679, 7141680, 7150272, 7162775, 7167155, 7169403, 7172215, 7177261, and 7208536.

Why it was recalled

Safety Mechanism Failure: the safety mechanism of the BD Vacutainer Push Button Collection Set with Pre-attached holder cannot be activated; thus the needle cannot retract into the rear barrel.

Root cause (FDA determination)

Material/Component Contamination

Action the firm took

BD sent Recall notification letters, Urgent Class II Product Recall, to customers and distributors on 12/10/07 through a third party, West Inc., Appleton, Wi. Mailings were sent return receipt requested. Letters requested immediate inventory search and product return. Contact number for questions was given as 1-800-631-0174

Recalling firm

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

Distribution

Distribution pattern: Worldwide-USA and Canada

Timeline

Recall initiated: 2007-11-20
Posted by FDA: 2008-01-23
Terminated: 2008-09-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #66592. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.