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Terminated

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

FDA Recall Z-0404-06 · Posted 2006-01-18

Recalling FirmBecton Dickinson & Company
Recall StatusTerminated
Product CodeFMF
Date Initiated2005-10-25
Date Terminated2006-06-21
Product Quantity2495 cases -- 2495000 syringes

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.

Firm Action

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

Root Cause

Other

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K992734BECTON DICKINSON SYRINGEBd Becton Dickinson Vacutainer Systems Preanalytic · 1999-10-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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