Recall Z-3191-2024— Merit Medical Systems, Inc.
Class II · Ongoing
Class II FDA medical device recall by Merit Medical Systems, Inc., initiated 2024-08-12. FDA's recall record names no specific 510(k) clearance for this event. Product: Custom Procedure Kit, REF: K12T-11077. Reason: 7F sheath introducers labeled as 7.5F.
- Recalling firm
- Merit Medical Systems, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-08-12
- Firm location
- South Jordan, UT, United States
Product description
Custom Procedure Kit, REF: K12T-11077
Reason for recall
7F sheath introducers labeled as 7.5F
Data sourced from openFDA. This site is unofficial and independent of the FDA.