FDA Enforcement
Class II
Ongoing
EasyPoint Needle, 25G x 5/8", REF: 82091
Recall: Z-1293-2024
·
Reported March 20, 2024
Enforcement
- Recall Number
- Z-1293-2024
- Event ID
- 93981
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Retractable Technologies, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 20, 2024
- Initiation Date
- February 5, 2024
- Classification Date
- March 14, 2024
- Address
- 511 Lobo Ln, N/A, Little Elm, TX, 75068-5295, United States
Description
EasyPoint Needle, 25G x 5/8", REF: 82091
Reason
The needle cannula of a retractable needle may detach from the needle holder in the patient.
Code Info
UDI-DI: 00613703820907. Lot: K220402. Expiration: 03/28/2027
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.
Quantity
477,600