—#51364

Product

BD Vacutainer Safety-Lok Blood Collection Set with Preattached Holder. Color green. 21 Gauge. Translucent, integrated protective shield that provides one-handed activation immediately after use, 0.75 in needle length, 12 in tubing, Luer adapter and holder, wings, sterile.

FDA product code: JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K980414
Affected lot / code info: Catalog # 368652 Lot Numbers: 5236082; 5236093; 5236095.

Why it was recalled

The BD Vacutainer Safety-Lok Blood Collection Set with Preattached Holder has a problem where the non-patient needle (in the holder) may become separated from the hub and remain the stopper of an evacuated blood collection tube.

Root cause (FDA determination)

Other

Action the firm took

Recall letters were sent to customers on 3/11/2007 via a third party, West Inc., Appleton, WI who will coordinate the mailing to all consignees.

Recalling firm

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

Distribution

Distribution pattern: Nationwide and Canada.

Timeline

Recall initiated: 2007-03-20
Posted by FDA: 2007-05-10
Terminated: 2007-07-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #51364. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.