Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0404-06

BD 1 mL Allergist tray with 27 G x 1/2 in. BD Safety Glide

Becton Dickinson & Co / initiated 2005-10-25 / Terminated

Becton Dickinson & Company began a recall of BD 1 mL Allergist tray with 27 G x 1/2 in. BD Safety Glide on . The reason FDA records is "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". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0404-06
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Becton Dickinson & Co
Product
BD 1 mL Allergist tray with 27 G x 1/2 in. BD Safety Glide.
Product code
FMF Syringe, Piston
Reason for recall
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.
FDA root cause
Other
Action
Recall notifications were sent to all direct consignees and potential end users on 10/25/2005 via UPS second day air.
Quantity in commerce
2495 cases -- 2495000 syringes
Distribution
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.
Product codes and lots
Reference Number 305950: Product Description: 1 mL 27G Allergist Tray Lot Number:  5167180; 5167183; 5111316; 5111317; 5082354; 5082355; 5052282; 5020329; 5020326; 4344954; 4344973; 4323198; 4323202.