Recall Z-2224-2021 ยท HBO Clip, Scalp
Integra LifeSciences Corp.
CODMAN RANEY SCALP CLIPS-Disposable cylindrical clips designed to provide hemostasis to the scalp wound edge. Part Number: 201037
| Date | Jun 1, 2021 |
| Status | Terminated |
| Reason | Packaging-pouches with wrinkles across the Tyvek side may compromise the integrity of the pouch's sterile barrier |
| Root cause | Process change control |
| Action | Integra notified consignees (Hospitals, Government facilities, and Distributors) by letter via FedX 2 Day Mail on June 1, 2021 and email to Distributor. Letter states reason for recall, health risk and action to take: We request that you take the following actions: 1. Customers a. If you do have units of the affected product listed in Table 1, remove it immediately from service. b. If you do have affected product, check the box on the enclosed form I do have affected product. Record the total quantity of the affected product that you have. c. If you do not have affected product, check the box |
| Quantity | 906 units |
| Distribution | US Nationwide Distribution - Foreign Distribution: Hong Kong |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.