COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units

FDA device recall Z-1578-2023 · posted 2023-05-10 · Open, Classified

Recall details

Recalling firm

Merit Medical Systems, Inc.

Reason for recall

Custom sheath Introducer contains incorrect needle size

Action taken

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 OEMorder@merit.com 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.

Root cause

Unknown/Undetermined by firm

Status

Open, Classified

Product code

DYB

Quantity affected

1186 units

Distribution

US Distribution to state of: Minnesota

Date initiated

2023-03-21

Date posted

2023-05-10

Location

South Jordan, UT

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