Recall Z-3116-2017 ยท FMI Needle, Hypodermic, Single Lumen
Becton Dickinson & Company
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
| Date | Jun 13, 2017 |
| Status | Terminated |
| Reason | Presence of loose polypropylene foreign matter above release specification. |
| Root 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 cons |
| Quantity | 1,249,200 units |
| Distribution | US Distribution to: TX, PA, VA, CA, NY, IL, MI, NC, SC and KS. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K951254 | SAFETYGLIDE NEEDLE Bd Becton Dickinson Vacutainer Systems Preanalytic, Oct 7, 1995 |