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Class 2 Device Recall Safety Glide |
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Date Initiated by Firm |
October 25, 2005 |
Date Posted |
January 18, 2006 |
Recall Status1 |
Terminated 3 on June 21, 2006 |
Recall Number |
Z-0403-06 |
Recall Event ID |
33966 |
510(K)Number |
K992734
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Product Classification |
Syringe, Antistick - Product Code MEG
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Product |
BD 1 mL BD Safety Glide Tuberculin syringe with 26 G x 3/8 in. BD needle. |
Code Information |
Reference Number 305946: Product Description: 1ml 26G Blister Lot #: 5201856; 5175735; 5146697; 5143522; 5111315; 5082352; 5052279; 5020322; 4344951; 4323197. |
Recalling Firm/ Manufacturer |
Becton Dickinson & Company 1 Becton Dr Franklin Lakes NJ 07417-1815
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For Additional Information Contact |
Greg Morgan 201-847-4344
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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.
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FDA Determined Cause 2 |
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 |
2697 cases -- 1078800 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
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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.
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510(K) Database |
510(K)s with Product Code = MEG and Original Applicant = BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
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