Custom Procedure Kit, REF: K12T-11077
Reported: October 2, 2024 Initiated: August 12, 2024 #Z-3191-2024
Product Description
Custom Procedure Kit, REF: K12T-11077
Reason for Recall
7F sheath introducers labeled as 7.5F
Details
- Recalling Firm
- Merit Medical Systems, Inc.
- Units Affected
- 24
- 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.
- Location
- South Jordan, UT
Frequently Asked Questions
What product was recalled? ▼
Custom Procedure Kit, REF: K12T-11077. Recalled by Merit Medical Systems, Inc.. Units affected: 24.
Why was this product recalled? ▼
7F sheath introducers labeled as 7.5F
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 2, 2024. Severity: Moderate. Recall number: Z-3191-2024.
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