—#46976

Product

BD Vacutainer Luer Adapter; Catalog #367290 and #367300.

FDA product code: JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K991088
Affected lot / code info: Catalog No: 367290 Lot Number 5305585; Catalog No: 367300 Lot Numbers 5307894; 5307896; 5307900. For European distribution, the products are shipped to Temse located in Belgium who handles the recall. Temse has been identified as recalling only the following products and lots: Catalog Number 364896 (Direct Draw Adapter), lots 5311376, 5312193, 5312201. Catalog Number 367300 (Luer Adapter), lots 5307894, 5307896, 5307900.

Why it was recalled

Firm received complaints indicating failure of the Non-Patient (NP) sleeve to function properly. This sleeve covers the cannula and prevents leakage during blood collection.

Root cause (FDA determination)

Other

Action the firm took

BD sent out recall notifications on 6/21/2006 to distributors and their direct account customers.

Recalling firm

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

Distribution

Distribution pattern: World wide-Products are distributed nationwide to distributors and direct accounts. The products are also distributed internationally to the following locations: Japan, Australia, Canada, Hong Kong, New Zealand. For European distribution, the products are shipped to Temse located in Belgium who handles the recall. Temse has been identified as recalling only the following products and lots: Catalog Number 364896 (Direct Draw Adapter), lots 5311376, 5312193, 5312201. Catalog Number 367300 (Luer Adapter), lots 5307894, 5307896, 5307900. Government accounts include the VAMC in Erie, PA;

Timeline

Recall initiated: 2006-06-21
Posted by FDA: 2006-09-09
Terminated: 2007-06-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #46976. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.