Z-1293-2024 Class II Ongoing
FDA device recall Z-1293-2024 was initiated by Retractable Technologies, Inc. on February 5, 2024 and is designated Class II. Reason for recall: The needle cannula of a retractable needle may detach from the needle holder in the patient. The recall status is ongoing. Affected quantity: 477,600.
Recall Details
- Product Type
- Devices
- Report Date
- March 20, 2024
- Initiation Date
- February 5, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 477,600
Product Description
EasyPoint Needle, 25G x 5/8", REF: 82091
Reason for Recall
The needle cannula of a retractable needle may detach from the needle holder in the patient.
Distribution Pattern
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.
Code Information
UDI-DI: 00613703820907. Lot: K220402. Expiration: 03/28/2027