FDA Enforcement
Class II
Ongoing
Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F)
Recall: Z-3190-2024
·
Reported October 2, 2024
Enforcement
- Recall Number
- Z-3190-2024
- Event ID
- 95234
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Merit Medical Systems, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 2, 2024
- Initiation Date
- August 12, 2024
- Classification Date
- September 20, 2024
- Address
- 1600 W Merit Pkwy, South Jordan, UT, 84095-2416, United States
Description
Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F)
Reason
7F sheath introducers labeled as 7.5F
Code Info
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)
Distribution
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.
Quantity
1892