Cook Lunderquist Ring Torque Wire Guide packaging breach may compromise sterility
Cook Incorporated is recalling Lunderquist Ring Torque Wire Guides due to a complete breach in the chevron seal of the packaging, which may compromise device sterility. The recall affects multiple lot numbers distributed nationwide and internationally.
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: This is an FDA Class II recall of a sterile medical device with compromised packaging. No illnesses or injuries have been reported. The potential sterility compromise of a surgical guidewire constitutes a risk-of-harm product where injury has not yet been reported, meeting the rubric criterion for a High severity rating.
Plain-English summary
Cook Incorporated is recalling Lunderquist Ring Torque Wire Guides, reference part numbers THSF-35-125-THG (G27031) and THSF-35-145-THG (G27033), due to a complete breach of the chevron seal in the device packaging.
The chevron seal maintains the sterility of the device prior to use. A complete breach may compromise the sterility of the affected devices, potentially exposing patients to contamination during clinical use.
The affected devices were distributed to distribution centers domestically and internationally. Affected lot numbers include 14804788 and 14804789 for part number G27031, and 14804789 and NS14804743 for part number G27033, all with an expiration date of June 21, 2027.
Healthcare facilities should quarantine the affected devices immediately and contact Cook Incorporated for replacements. Do not use the affected devices. Report any injuries or adverse events related to this recall to the FDA and the device manufacturer.
The recalled product
- Product
- Lunderquist -Ring Torque Wire Guide, Guidewire Reference Part Number/GPN THSF-35-125-THG G27031 THSF-35-145-THG G27033
- Manufacturer
- Cook Incorporated
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 24 recalled by Cook Incorporated under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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