EasyPoint Needle, 25G x 5/8", REF: 82091
This recall is currently active, issued March 14, 2024. It was issued by Retractable Technologies, Inc..
- Company
- Retractable Technologies, Inc.
- Recall Initiated
- February 5, 2024
- Posted
- March 14, 2024
- Recall Number
- Z-1293-2024
- Quantity
- 477,600
- Firm Location
- Little Elm, TX
- Official Source
- View on FDA website ↗
Reason for Recall
The needle cannula of a retractable needle may detach from the needle holder in the patient.
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.
Lot / Code Info
UDI-DI: 00613703820907. Lot: K220402. Expiration: 03/28/2027
Root Cause
Process control
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