COBRA-OS, custom Sheath Introducer Kit, 4 French, REF:… recallZ-1578-2023 · Merit Medical Systems, Inc. · initiated Mar 21, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Merit Medical Systems, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Custom sheath Introducer contains incorrect needle size
FDA root cause category: Unknown/Undetermined by firm
What the company is doing
On March 21, 2023 MeritMedical issued a "Urgent Medical Device Recall Notice" to affected consignees via E-Mail. In addition to informing them about the recall, MeritMedical asked consignees to take the following actions: 1. Please immediately determine if any of the devices identified in the attached Customer Response Form (CRF) are within your facility, quarantine them, and discontinue use and distribution. 2. Ensure that applicable personnel within your organization are made aware of this field action. 3. If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is immediately shared with them and note the quantity distributed on the CRF. Additional distribution details may be required by health authorities. 4. Please fill out, scan and email the completed Customer Response Form to Customer Service at [email protected] within seven (7) calendar days. All affected product shipped to you must be accounted for on the CRF. 5. Please immediately return all affected lots in your possession to Merit, per the instructions in the attached CRF. 6. If you have any questions concerning this communication, please don t hesitate to contact your Merit OEM Sales Representative or Merit OEM Customer Service at (800)-637-4839| Hours: 8 am to 5 pm MST | Mon-Fri.
Recall details
- Recall number
- Z-1578-2023
- Status
- Open, Classified
- Initiated by the company
- Mar 21, 2023
- Posted by the FDA
- May 10, 2023
- Recalling firm
- Merit Medical Systems, Inc.
- Quantity
- 1186 units
- Product code
- DYB
- FDA submissions
- K070159
- Distribution
- US Distribution to state of: Minnesota
Product description
COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units
Code information (models, lots, serial numbers)
Lot # H2122096S1; UDI-DI: (00)884450525197
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- COBRA-OS 00884450525197Merit Medical Systems, Inc. · DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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