Recall Z-0259-2020 ยท DQX Wire, Guide, Catheter
Anewmed Corporation
Various products which were contract sterilized.
| Date | May 23, 2019 |
| Status | Open, Classified |
| Reason | The contract sterilizer did not have adequate packaging data to support the 2-year shelf life. |
| Root cause | Other |
| Action | AnewMed Corporation notified customers on about 05/23/2019 via "URGENT NOTICE VOLUNTARY RECAL OF MEDICAL DEVICES" letter sent certified mail. Instructions included to examine inventory for affected devices and either return them to AnewMed for a credit or destroy them. Customers were also instructed to complete and return the provided Reply Card and indicate whether devices will be return or have been discarded. Questions or additional details can be obtained from Rob Bennison or Nykysha Anderson at 770-263-9633, Monday-Friday, 8:30 AM to 4:40 PM Eastern Time. |
| Quantity | 1,749 devices |
| Distribution | Nationwide distribution in the states of AL, CO, FL, IN, KY, MS, NC, OH, SC, TN, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.