Torq-Flex Wire Guide Guidewires Recalled Due to Packaging Seal Defect
Cook Incorporated is recalling Torq-Flex Wire Guide guidewires because the packaging chevron seal may be breached, potentially compromising device sterility. The affected units were distributed domestically 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: Class II sterile medical device with complete packaging seal breach potentially compromising sterility. Meets High severity threshold as a risk-of-harm product where injury has not been reported.
Plain-English summary
Cook Incorporated is recalling Torq-Flex Wire Guide Australian Modification guidewires (part number STF-18-40-AUST, UDI-DI 00827002073043) because affected units from specific production lots may have a complete breach of the chevron seal of the packaging. This breach may compromise the sterility of the devices.
The recall affects 149 units distributed domestically throughout the United States and internationally. A breach in the packaging seal creates a risk that contaminants could compromise device sterility.
Affected lot numbers are 14788615, 14816230, and 14836977. Healthcare providers and patients using affected devices should contact Cook Incorporated for guidance regarding device replacement and handling procedures.
The recalled product
- Product
- Torq-Flex Wire Guide Australian Modification, Guidewire Reference Part Number/GPN STF-18-40-AUST G07304
- Manufacturer
- Cook Incorporated
- Category
- Medical Device — Guidewire
- Affected units
- 149
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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