COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units
Reported: May 17, 2023 Initiated: March 21, 2023 #Z-1578-2023
Product Description
COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units
Reason for Recall
Custom sheath Introducer contains incorrect needle size
Details
- Recalling Firm
- Merit Medical Systems, Inc.
- Units Affected
- 1186 units
- Distribution
- US Distribution to state of: Minnesota
- Location
- South Jordan, UT
Frequently Asked Questions
What product was recalled? ▼
COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units. Recalled by Merit Medical Systems, Inc.. Units affected: 1186 units.
Why was this product recalled? ▼
Custom sheath Introducer contains incorrect needle size
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 17, 2023. Severity: Moderate. Recall number: Z-1578-2023.
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