Medical Guidewire Recalled for Packaging Defect Affecting Sterility
Cook Incorporated is recalling Movable Core Wire Guide (Tefcor) guidewires due to a packaging defect where the chevron seal may be breached, potentially compromising device 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 for potential sterility compromise due to packaging seal defect. This represents a risk-of-harm product where no injuries have been reported, meeting criteria for High (3) severity.
Plain-English summary
Cook Incorporated is recalling Movable Core Wire Guide (Tefcor) guidewires (Reference Part Number/GPN: TMT-35-145, G01677) due to a packaging defect. Cook Medical 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 recalled devices were distributed nationwide within the United States and worldwide internationally. Lot number 14808818 (expiration date 22-06-2027) is subject to this recall.
The recalled product
- Product
- Movable Core Wire Guide (Tefcor), Guidewire (OUS ONLY) Reference Part Number/GPN TMT-35-145 G01677
- 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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