Coons Interventional Guidewire Recall Due to Packaging Sterility Breach
Cook Incorporated is recalling Coons Interventional Wire Guide devices because the chevron seal on packaging may be completely breached, compromising sterility. 1,236 units were distributed.
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 with potential sterility compromise from packaging defect. Guidewires are invasive devices where compromised sterility poses infection risk. No illnesses or injuries reported; the hazard is theoretical.
Plain-English summary
Cook Incorporated is recalling Coons Interventional Wire Guide devices, which are sterile medical devices used in interventional procedures. The recalled devices include multiple reference part numbers and lot codes distributed domestically and worldwide.
Cook Medical identified that the chevron seal on the packaging of affected devices may be completely breached. A breached seal can compromise the sterility of the medical device.
Users of affected products should stop using them immediately. Healthcare providers who have received these devices should identify the affected lot codes from their inventory and cease use. Patients should inform their healthcare providers if they have received a procedure using an affected device. Contact Cook Incorporated or the FDA for more information.
The recalled product
- Product
- Coons Interventional Wire Guide, Guidewire; Reference Part Number/GPN: THSF-35-145-COONS G02356 THSF-38-145-COONS G02324 THSF-35-180-COONS G02621 THSF-35-80-COONS G12268
- Manufacturer
- Cook Incorporated
- Affected units
- 1,236
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.
See all 24 products in this recall →Related recalls
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