Cook Guidewire Devices Recalled for Packaging Defect and Sterility Compromise
Cook Incorporated is recalling fixed core wire guide devices due to packaging defects that may compromise device sterility. Approximately 5,669 units were distributed in the US and 5,286 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: FDA Class II recall involving potential sterility compromise of medical devices due to packaging defects. No illnesses or injuries are reported, qualifying this as a risk-of-harm case without reported injury per the rubric.
Plain-English summary
Cook Incorporated is recalling fixed core wire guide (straight) guidewire devices due to potential sterility compromise. The manufacturer identified that devices from affected lots may have a complete breach of the chevron seal of the packaging, which could compromise the devices' sterility.
The affected devices include multiple reference part numbers. In total, 5,669 units were distributed in the United States and 5,286 units internationally, with US distribution nationwide and international distribution worldwide.
No illnesses or injuries have been reported in connection with this recall. Affected lot numbers and expiration dates are detailed in the official FDA recall notice. Healthcare providers and patients should refer to the FDA notice for complete information about the specific devices affected.
The recalled product
- Product
- Fixed Core Wire Guide (Straight), Guidewire Reference Part Number/GPN: C-SF-18-30 G02261 C-SF-25-40 G01937 TSF-18-260 G00590 C-SF-25-50 G01938 TSF-35-180 G00652 C-SF-18-40 G02255 TSF-25-145 G00617 TSF-32-145 G00638 C-SF-15-50 G02274 TSF-18-145 G00587 TSF-18-50 G00593…
- Manufacturer
- Cook Incorporated
- Category
- Medical Device
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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