Recall Z-2513-2023 ยท DWS Instruments, Surgical, Cardiovascular
Cook Vandergrift, Inc.
Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of cardiac leads. Order Number (GPN): G20003 Reference Part Number (RPN): LR-CLP001
| Date | Sep 1, 2023 (initiated Jul 24, 2023) |
| Status | Open, Classified |
| Reason | Sterility of device may be compromised due to breach of the chevron seal of the packaging |
| Root cause | Under Investigation by firm |
| Action | Cook Medical Vandergrift issued URGENT: Medical Device Recall letter on July 24, 2023. Letter states reason for recall, health risk and action to take: Actions to be Taken by the Customer 1. Examine inventory immediately to determine if you have affected product(s) and quarantine any affected product that remains unused. Immediately cease all further distribution and use of the affected products. 2. Return the affected product(s) to Cook Medical Vandergrift with a copy of the Acknowledgement and Receipt Form to receive a product credit. Refer to the Acknowledgement and Receipt Form for return |
| Quantity | 15,951 |
| Distribution | Worldwide distribution - US Nationwide including PR and the countries of AE, AT, AU, BE, BN, BY, CA, CH, CL, CO, CZ, DE, DK, ES, FI, FR, GB, GT, HK, HU, IE, IL (EUDC), IL (NADC), IT, JP, KW, MX, NL, NO, PL, PR, PT, SE, TH, TR, UY, ZA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.