—#118556

Product

BD Vacutainer Multiple Sample and Direct Draw Luer Adapter BD Franklin Lakes, NJ 07417 USA A sterile non-invasive device used to connect venous access devices such as needles, blood collection sets, ad infusion sets to blood collection tubes.

FDA product code: JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection
Device class: Class 2
Medical specialty: Clinical Chemistry
Affected lot / code info: Marketing Status: Class II, 510K # K991088 Device Listing Number: D030347 Catalog number 367290, 367300 (CE), 368491, and 303380.

Why it was recalled

BD Vacutainer Multiple Sample and Direct Draw Luer Adapter may have blood leakage and low draw volume.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

BD sent a Product Advisory Notice dated May 3, 2013, via UPS to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discard filled tubes since it is possible they will contain less blood volume (low draws), replace the Luer Adaptor unit being used with a fresh unit, and continue to draw blood samples using the fresh unit. Customers with questions were instructed to contact BD Technical Service at 1-800-631-0174, Option 4, or contact them through website: www.bd.com/vacutainer/contact. For questions regarding this recall call 201-847-6800.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2013-05-01
Posted by FDA: 2013-08-07
Terminated: 2015-12-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #118556. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.