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
FDA Recall Z-3116-2017 · Posted None
Recalling FirmBecton Dickinson & Company
Recall StatusTerminated
Product CodeFMI
Date Initiated2017-06-13
Date Terminated2020-06-22
Product Quantity1,249,200 units
Reason for Recall
Presence of loose polypropylene foreign matter above release specification.
Firm 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 [email protected]. 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 [email protected].
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.
Root Cause
Process control
Distribution Pattern
US Distribution to: TX, PA, VA, CA, NY, IL, MI, NC, SC and KS.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.