Z-3190-2024 Class II Ongoing
FDA device recall Z-3190-2024 was initiated by Merit Medical Systems, Inc. on August 12, 2024 and is designated Class II. Reason for recall: 7F sheath introducers labeled as 7.5F The recall status is ongoing. Affected quantity: 1892.
Recall Details
- Product Type
- Devices
- Report Date
- October 2, 2024
- Initiation Date
- August 12, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1892
Product Description
Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F)
Reason for Recall
7F sheath introducers labeled as 7.5F
Distribution Pattern
Worldwide - US Nationwide distribution in the states of WI, MN, TX, PA, GA, NE, CA, AR, MS, MA, MI, OH, CO, NV, OR, AZ, NC and the country of Mexico.
Code Information
REF/UDI-DI/Lot (Expiration Date): PSI-7F-11-038 Version F/00884450708835/H2874685 (09-Mar-2027), H2878374 (26-FEB-2027), H2904232 (11-MAY-2027)