Cook Lead Clipper Cardiac Device Sterility Recall Due to Packaging Defect
Cook Vandergrift is recalling approximately 15,951 Cook Lead Clipper devices due to potential sterility compromise from packaging seal breaches. The surgical tool is used for cardiac lead retrieval procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall for a sterile surgical device with potential sterility compromise due to packaging defects. The hazard represents a risk of harm in a critical medical application per the rubric's definition of High severity for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Cook Vandergrift, Inc. is recalling the Cook Lead Clipper (Order Number G20003), an auxiliary surgical tool indicated for percutaneous retrieval of cardiac leads. The recall affects approximately 15,951 units distributed worldwide.
The sterility of the device may be compromised due to a breach of the chevron seal of the packaging. Affected devices are identified by Device Identifier (01)00827002200036(17) and the associated lot numbers listed in the FDA recall notice.
The recalled devices were distributed worldwide, including throughout the United States and Puerto Rico, and to multiple countries including Canada, European nations, Japan, the Middle East, and South America.
This is a Class II recall issued by the U.S. Food and Drug Administration.
The recalled product
- 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
- Manufacturer
- Cook Vandergrift, Inc.
- Affected units
- 15,951
Distribution
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