Recall Z-0887-2022 ยท DWS Instruments, Surgical, Cardiovascular
Maquet Cardiovascular, LLC
Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF UA-5001.
| Date | Feb 9, 2022 |
| Status | Open, Classified |
| Reason | Potential for corrosion on the pins of the Ultima Activator II Reusable Drive Mechanism. Harms may include allergic reaction, metal toxicity, and other delayed responses. |
| Root cause | Mixed-up of materials/components |
| Action | On February 14, 2022, a customer notification letter was issued via FedEx. Customers are instructed to quarantine and return all affected product and notify all users within the hospital/facility. Please note affected lot numbers appear on the device package only. If the packaging has been discarded, the affected devices can be identified by Device Component Lot number, which is etched onto all 3 device components on side of handle and on underside above each pin. Customers are to complete and return the response form by email or fax. Distributors are to forward this document to customers for |
| Quantity | 60 |
| Distribution | Worldwide - United States (AL, AZ, CA, FL, IL, KY, LA, MO, MT, NM, OH, PA, TX, WI), Germany, Republic of Korea (South Korea), Russia, Thailand, United Arab Emirates. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.