Recall Z-0079-2023 ยท GDZ Handle, Scalpel
Steris Corporation
Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360
| Date | Oct 12, 2022 (initiated Sep 2, 2022) |
| Status | Terminated |
| Reason | The scalpel holder may separate from the handle for certain lots. If the tip falls off during use, it could fall into the patient's mouth which may result in a cut to the patient's mouth and also presents a choking hazard. |
| Root cause | Process design |
| Action | Starting September 2, 2022, Hu-Friedy notified all affected customers and distributors via Urgent Medical Device Recall letters. Customers were instructed to immediately destroy all on-hand inventory of the affected lots of K360 Scalpel Handles. Distributors should identify and notify any of their customers who have received further distributed product. Hu-Friedy will issue credit upon receipt of completed response forms. |
| Quantity | 5 US; 62 OUS |
| Distribution | Distribution to US states of IL, MA, NC, SC, and TN, Canada, China, Japan, Malaysia, Turkey, Great Britain, and India. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.