Recall Z-1132-2022 ยท MCZ Suture Removal Kit
Stradis Healthcare
Surgical Suture Kit
| Date | Apr 22, 2022 |
| Status | Terminated |
| Reason | There is uncertainty about the integrity of the methods used to ensure the sterile barrier integrity. |
| Root cause | Under Investigation by firm |
| Action | The firm, Stradis Health, initiated an "URGENT: MEDICAL DEVICE RECALL" on 04/22/2022 via email. The letter instructs the consignee to examine your inventory and immediately quarantine any affected product; contact Stradis Customer Service to arrange or return, shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Service can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. Notify their customer within 48 hours and the customers should contact the firm to arrange for a return. The firm is also requesting that the consignee |
| Quantity | 7340 units |
| Distribution | US Distribution to NC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.