Recall Z-2513-2023— Cook Vandergrift, Inc.
Class II · Ongoing
Class II FDA medical device recall by Cook Vandergrift, Inc., initiated 2023-07-24. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. Reason: Sterility of device may be compromised due to breach of the chevron seal of the packaging.
- Recalling firm
- Cook Vandergrift, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-07-24
- Firm location
- Vandergrift, PA, United States
Product description
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
Reason for recall
Sterility of device may be compromised due to breach of the chevron seal of the packaging
Data sourced from openFDA. This site is unofficial and independent of the FDA.