EasyPoint Needle, 25G x 5/8", REF: 82091
FDA device recall Z-1293-2024 · posted 2024-03-14 · Open, Classified
Recall details
- Recalling firm
- Retractable Technologies, Inc.
- Reason for recall
- The needle cannula of a retractable needle may detach from the needle holder in the patient.
- Action taken
- 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 questions can email the firm at regulatory@retractable.com
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- FMI
- Quantity affected
- 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.
- Date initiated
- 2024-02-05
- Date posted
- 2024-03-14
- Location
- Little Elm, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EASYPOINT NEEDLE (K133635) | Retractable Technologies, Inc. | 2014-06-17 |