Cook Guidewire Products Recalled Due to Compromised Sterile Packaging
Cook Incorporated is recalling Fixed Core Wire Guide products due to potential breach of sterile packaging seals. Affected devices may have compromised sterility.
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 with no reported illnesses or injuries, but involving potential sterility compromise of a surgical device. Per the rubric, risk-of-harm products where injury has not yet been reported receive a score of 3.
Plain-English summary
Cook Incorporated is recalling certain Fixed Core Wire Guide (Guidewire) products due to potential compromised sterility. The company identified that devices from affected lots may have a complete breach of the chevron seal of the packaging. This breach may compromise the sterility of the affected devices.
The affected products are identified by reference part numbers THSCF-25-180-3 (G02165) and TSCF-25-80-3 (G00476). A total of 58 units were distributed in the United States and 5 units were distributed internationally. Specific lot numbers and expiration dates are available in the FDA recall notice.
The recalled product
- Product
- Fixed Core Wire Guide, Guidewire Reference Part Number/GPN THSCF-25-180-3 G02165 TSCF-25-80-3 G00476
- 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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