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U.S. Department of Health and Human Services

Class 2 Device Recall BD Needle 22GA 11/2in SafetyGlide(TM)

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  Class 2 Device Recall BD Needle 22GA 11/2in SafetyGlide(TM) see related information
Date Initiated by Firm June 13, 2017
Create Date September 11, 2017
Recall Status1 Terminated 3 on June 22, 2020
Recall Number Z-3116-2017
Recall Event ID 77650
510(K)Number K951254  
Product Classification Needle, hypodermic, single lumen - Product Code FMI
Product BD Needle 22GA 1-1/2in SafetyGlide(TM) Non Sterile, Bulk, REF 301701

The BD SafetyGlide(TM) needle is intended to be used for general purpose injection, aspiration of fluids from parts of the body below the surface of the skin, injection into intravenous ports and tubings external to the patient. The needle stick prevention feature of the device contains a mechanism that covers the needlepoint after use. Bulk Non Sterile configuration is intended for further manufacturing, processing or repackaging
Code Information Lot Numbers: 6211579, 6271695, 6154760, 6154765 & 5268868
Recalling Firm/
Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact Mark Yale
Manufacturer Reason
for Recall
Presence of loose polypropylene foreign matter above release specification.
FDA Determined
Cause 2
Process control
Action The firm, BD, sent an "URGENT MEDICAL DEVICE RECALL" notices dated June 12, 2017 to their distributors and customers (manufacturers of finished devices) via UPS ground mail on June 13, 2017. Distributors were advised to immediately review inventory, quarantine product subject to recall and to discontinue the distribution of the affected product and if the product was further distributed, please notify any accounts or additional locations that may have received the recalled product from you. If the customer has conducted re-packaging operations using the recalled bulk product, this is considered a new product. Customers are advised to complete and return the Business Response Card form via fax to 201-827-6990 or email to Becky-Saggau@bd.com. Return all affected products with the completed Business Response Card form following the instruction on the enclosed packing instruction. Upon receipt of the returned product, BD will issue product replacement. If the consignee did not have any of the affected lots in your inventory, they were directed to complete the Business Response Card form indicating you have zero (0) quantity and fax the completed form back to BD at 201-847-6990 or email the completed form to Becky-Saggau@bd.com. For general questions or require further assistance, please contact 201-847-4267 between 8AM and 5 PM ET Monday through Friday. For questions specific to assessment of need for further actions for kit packers, please contact 201-847-5880.
Quantity in Commerce 1,249,200 units
Distribution US Distribution to: TX, PA, VA, CA, NY, IL, MI, NC, SC and KS.
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 = FMI and Original Applicant = BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC