Recall Z-3190-2024
Merit Medical Systems, Inc. · initiated August 12, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F)
Codes / lots: 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)
Reason for recall
7F sheath introducers labeled as 7.5F
FDA-determined cause: Labeling mix-ups
Action taken
On 8/12/24, recall notices were mailed or emailed to customers who were asked to do the following: 1) Determine if any of the products identified in the attached Customer Response From (CRF) are within your facility. 2) Ensure that appropriate personnel within your organization are made aware of this field action. 3) If the product has been further distributed to other facilities, institutions, or manufacturers, ensure this notice is immediately shared with them. Additional distribution details may be required by health authorities. 4) Post this "URGENT MEDICAL DEVICE RECALL NOTICE" on or near the affected products. Product may continue to be used once this recall notice is placed on or near them. 5) Complete and return the response form via email to response@merit.com If you have any questions concerning this communication, contact the firm's Sales Representative or Customer Service at +1 800 356 3748 | Hours: 6 am to 6 pm MST, Mon-Fri.
Details
- Recall number
- Z-3190-2024
- Initiated
- August 12, 2024
- Posted by FDA
- September 20, 2024
- Product code
- DRE – Dilator, Vessel, For Percutaneous Catheterization
- Quantity
- 1892
- 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.
- Recalling firm
- Merit Medical Systems, Inc., South Jordan, UT
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-3191-2024 Class II | Custom Procedure Kit, REF: K12T-110777F sheath introducers labeled as 7.5F | 08/12/2024Open, Classified |