—#42817

Product

BD 1 mL BD Safety Glide tuberculin syringe with 27 G x 1/2 in. BD needle.

FDA product code: FMF — Syringe, Piston
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K992734
Affected lot / code info: Reference Number 305945: 1mL 27G Blister: Lot #: 5201851; 5201855; 5201853; 5175734; 5175732; 5175731; 5175730; 5146694; 5146689; 5146686; 5146691; 5146688; 5115764; 5111314; 5111313; 5082345; 5082341; 5082350; 5082344; 5052275; 5052276; 4344969; 4344970; 4344930; 4344978; 4344934; 4323196; 4323195; 4323194; 4296986.

Why it was recalled

Safety mechanisms on the syringes are rotating too freely. This can result in the safety mechanism not holding its rotational position and increasing risk of an accidental needle-stick.

Root cause (FDA determination)

Other

Action the firm took

Recall notifications were sent to all direct consignees and potential end users on 10/25/2005 via UPS second day air.

Recalling firm

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

Distribution

Distribution pattern: Product was distributed nationwide to 450 consignees composed of wholesalers, hospitals, and medical supply distributors. There is a Canadian customer, Dufort & Lavigne, Montreal, Quebec, Canada. Government customers include VAMC New Orleans, New Orleans, LA; Fox Army Health Center, Redstone Arsenal, AL; Moncrief Army Community Hospital, Columbia, SC; US Naval Med. Ctr., Portsmouth, VA; USAF Hill AFB 649 Medical Group, Hill Air Force Base, UT; VAMC Ann Arbor, MI; VAMC East Orange, NJ; VAMC Tuskegee, AL; McDonald Army Community Hospital, Newport News, VA.

Timeline

Recall initiated: 2005-10-25
Posted by FDA: 2006-01-18
Terminated: 2006-06-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #42817. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.