—#48949

Product

BD Vacutainer Luer-Lok Access Device Holder with Pre-Attached Multiple Sample Adapter Sterile, Do Not Reuse, Keep away from heat, Rx only Ref # 364902 200 (4X50) BD Franklin Lakes, NJ 07417

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: UPC (01)30382903649021 Catalog # 364902 Lot # 6138499 Exp. 4/09 Catalog # 364902 Lot # 6144043 Exp. 4/09 Catalog # 364902 Lot # 6144082 Exp. 4/09 Catalog # 364902 Lot # 6144090 Exp. 4/09 Catalog # 364902 Lot # 6144128 Exp. 4/09 Catalog # 364902 Lot # 6150373 Exp. 4/09 Catalog # 364902 Lot # 6150365 Exp. 5/09 Catalog # 364902 Lot # 6153085 Exp. 5/09 Catalog # 364902 Lot # 6154356 Exp. 5/09 Catalog # 364902 Lot # 6154358 Exp. 5/09 Catalog # 364902 Lot # 6173027 Exp. 5/09 Catalog # 364902 Lot # 6173028 Exp. 5/09 Catalog # 364902 Lot # 6178307 Exp. 5/09 Catalog # 364902 Lot # 6178357 Exp. 5/09

Why it was recalled

Reports of failure of the Luer Lok Access Device to lock securely to certain catheter devices because the male luer taper surface is not within the specification.

Root cause (FDA determination)

Other

Action the firm took

Recall notification was sent 9/8/06 to all direct accounts and distributors by US mail, return receipt requested. Consignees were asked to send product back to BD with the packing slip and shipping labels enclosed

Recalling firm

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

Distribution

Distribution pattern: Worldwide, including USA, Canada, and Australia.

Timeline

Recall initiated: 2006-09-08
Posted by FDA: 2006-12-06
Terminated: 2007-05-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #48949. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.