Recall Z-3191-2024 ยท OEQ Angiography/Angioplasty Kit
Merit Medical Systems, Inc.
Custom Procedure Kit, REF: K12T-11077
| Date | Sep 20, 2024 (initiated Aug 12, 2024) |
| Status | Open, Classified |
| Reason | 7F sheath introducers labeled as 7.5F |
| Root cause | Labeling mix-ups |
| Action | On 8/12/24, recall notices were mailed or emailed to customers who were asked to do the following: 1) Determine if any of the products identified in the attached Customer Response From (CRF) are within your facility. 2) Ensure that appropriate 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, ensure this notice is immediately shared with them. Additional distribution details may be required by health authorities. 4) Post this "URGENT MEDICAL DEVICE RECALL NOTICE" on or nea |
| Quantity | 24 |
| Distribution | Worldwide - US Nationwide distribution in the states of WI, MN, TX, PA, GA, NE, CA, AR, MS, MA, MI, OH, CO, NV, OR, AZ, NC and the country of Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.