Recall Z-0751-2021 ยท OEQ Angiography/Angioplasty Kit
Merit Medical Systems, Inc.
Custom Procedure Kit, Cardiac Cath Pack, Product Code: K12T-10996 Rev. B, Sterile EO, Rx Only, (01)00884450515105 For Angiography/angioplasty. The contents of the kit are surgical drapes, gowns, towels, medicine cups, needles, various bowls, pen and label set (PAL), scalpel, several syringes, chloraprep, table cover, and gauze to be used in a Cardiac Cath procedure.
| Date | Nov 10, 2020 |
| Status | Terminated |
| Reason | Angiography/Angioplasty custom kits contain header bags which may not be fully sealed, resulting in a compromised sterile barrier. This could result in exposure to non-sterile devices which may lead to an infection requiring medical treatment. |
| Root cause | Packaging process control |
| Action | On November 10, 2020, Merit Medical sent a "Urgent Product Recall Notice to affected consignees via FedEx mail In addition, to informing consignees about the recall issue, the firm ask 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 |
| Quantity | 80 kits |
| Distribution | US distribution to: KY, RI, and MD |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.