Sheath Introducer Kit with Incorrect Needle Size Recalled
Merit Medical Systems is recalling COBRA-OS Sheath Introducer Kits due to an incorrect needle size that may affect proper insertion during medical procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a functional defect in a medical device classified as FDA Class II without reported hospitalizations or injuries. It qualifies as a risk-of-harm product where injury has not yet been reported, placing it at score 3 per the rubric.
Plain-English summary
Merit Medical Systems, Inc. is recalling 1,186 units of COBRA-OS custom Sheath Introducer Kits, 4 French, Lot #H2122096S1.
The recalled kits contain an incorrect needle size, which may affect proper insertion and device functionality. This defect could compromise patient safety during medical procedures using the kits.
The affected kits were distributed to Minnesota. The recall applies to product with Lot #H2122096S1 and UDI-DI (00)884450525197.
Patients or healthcare providers who have used or are in possession of these kits should contact Merit Medical Systems for instructions on return, replacement, or disposal. Healthcare facilities should review their inventory and quarantine any affected units.
The recalled product
- Product
- COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units
- Manufacturer
- Merit Medical Systems, Inc.
- Affected units
- 1,186
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # H2122096S1
- UDI-DI: (00)884450525197
Distribution
Distributed in 1 state:
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