Recall Z-0027-2020 ยท OES Cardiac Catheterization Kit
Merit Medical Systems, Inc.
Custom Procedure Kit, Vein Kit, Product Code/REF: K12T-10167, single use, RX Only, Sterile EO, UDI: (01) 00884450390580
| Date | Oct 26, 2018 |
| Status | Terminated |
| Reason | Labeling error; It was identified that a Procedure Kit/Tray contained incorrect latex labeling information (i.e. indicated Latex Free) |
| Root cause | Error in labeling |
| Action | On 10/26/2018, Merit customer service representative placed telephone calls to consignees to inform them of the latex contained in the kits/trays. On 10/29/2018, the firm sent an "Urgent Product recall Notice" to all affected consignees via FedEx. The recall notification informed customers of the following: 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. |
| Quantity | 24 kits |
| Distribution | U.S.: VA, IL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.