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U.S. Department of Health and Human Services

Class 2 Device Recall Safety Glide

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  Class 2 Device Recall Safety Glide see related information
Date Initiated by Firm October 25, 2005
Date Posted January 18, 2006
Recall Status1 Terminated 3 on June 21, 2006
Recall Number Z-0402-06
Recall Event ID 33966
510(K)Number K992734  
Product Classification Syringe, Piston - Product Code FMF
Product BD 1 mL BD Safety Glide tuberculin syringe with 27 G x 1/2 in. BD needle.
Code Information 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.
Recalling Firm/
Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact Greg Morgan
Manufacturer 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 Determined
Cause 2
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 6920 cases -- 2768000 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FMF and Original Applicant = BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC