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

• Date Initiated by Firm: June 13, 2017
• Create Date: September 11, 2017
• Recall Status: Terminated 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/ Manufacturer: Becton Dickinson & Company; 1 Becton Dr; Franklin Lakes NJ 07417-1815
• For Additional Information Contact: Mark Yale; 201-847-5880
• Manufacturer Reason for Recall: Presence of loose polypropylene foreign matter above release specification.
• FDA Determined Cause: 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