The Recall Desk
HighFDA (Devices)·Z-1578-2023·Announced 2023-05-17

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.

What this means for you

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.
Category
Medical Device — Catheter Accessory
Hazard
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:

Related recalls

Same manufacturer · Merit Medical Systems, Inc.

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