Recall Z-1578-2023 ยท DYB Introducer, Catheter
Merit Medical Systems, Inc.
COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units
| Date | May 10, 2023 (initiated Mar 21, 2023) |
| Status | Open, Classified |
| Reason | Custom sheath Introducer contains incorrect needle size |
| Root cause | Unknown/Undetermined by firm |
| Action | 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 |
| Quantity | 1186 units |
| Distribution | US Distribution to state of: Minnesota |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070159 | PRELUDE SHEATH INTRODUCER Merit Medical Systems, Inc., Jun 21, 2007 |