—#157172

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

FDA product code: FMI — Needle, Hypodermic, Single Lumen
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K951254
Affected lot / code info: Lot Numbers: 6211579, 6271695, 6154760, 6154765 & 5268868

Why it was recalled

Presence of loose polypropylene foreign matter above release specification.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Becton Dickinson & Company
Address: 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

Distribution pattern: US Distribution to: TX, PA, VA, CA, NY, IL, MI, NC, SC and KS.

Timeline

Recall initiated: 2017-06-13
Terminated: 2020-06-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #157172. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.