Recall Z-1293-2024 ยท FMI Needle, Hypodermic, Single Lumen
Retractable Technologies, Inc.
EasyPoint Needle, 25G x 5/8", REF: 82091
| Date | Mar 14, 2024 (initiated Feb 5, 2024) |
| Status | Open, Classified |
| Reason | The needle cannula of a retractable needle may detach from the needle holder in the patient. |
| Root cause | Process control |
| Action | On 2/5/24, recall notices were sent to customers and distributors who were asked to do the following: 1) Segregate, quarantine, and discontinue use and distribution of affected devices. 2) Inform all personnel who have received or are receiving affected devices that they should not use affected devices. 3) If affected product was further distributed, notify these additional customers immediately. When notifying customers include a copy of the recall notice, label images, and the response form. 4) Complete and return the response form to rtiservice@retractable.com Customers with additional q |
| Quantity | 477,600 |
| Distribution | US Nationwide distribution including in the states of NY, FL, IL, MA, UT, NJ, AZ, MO, WA, NC, CA, TX, NV, IN, PA, VA, IA, GA, TN, MI, OH, OK, CO, OR, SC, MN, CT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133635 | EASYPOINT NEEDLE Retractable Technologies, Inc., Jun 17, 2014 |