—#31303

Product

VACUTAINER Brand Push Button Blood Collection Sets.

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: Batch # 3218665

Why it was recalled

A hole was noticed in the 'blister pack' that is used to package the device and provides the sterility barrier. Sterility could be compromised.

Root cause (FDA determination)

Other

Action the firm took

BD Sales Organization directly contacted all customers with return instructions on December 22, 2003. All consignees responded.

Recalling firm

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

Distribution

Distribution pattern: The firm was able to determine that the product was distributed to 3 customers: Long Beach Memorial, Long Beach, CA; Potomac Hospital, Woodbridge Prince William, VA; and St. Joseph Hospital, Orange, CA.

Timeline

Recall initiated: 2003-12-17
Posted by FDA: 2004-02-25
Terminated: 2004-03-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #31303. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.