Vandergrift, PA, United States
Cook Vandergrift, Inc. recalls
1 recall recorded since 2018, most recently on 24 July 2023. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 24 July 2023
- Reason
- Sterility of device may be compromised due to breach of the chevron seal of the packaging
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2513-2023
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.