Cook Rosen Curved Wire Guide Recall: Sterility Concerns
Cook Incorporated is recalling specific lots of Rosen Curved Wire Guide guidewires due to a complete breach of the packaging seal that may compromise device sterility. Affected devices were distributed nationwide in the US and worldwide.
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: This is a risk-of-harm medical device product where no illnesses or injuries have been reported. The hazard—compromised sterility due to packaging breach—is serious for a surgical guidewire, but without reported patient harm, the score is at most 3 per the rubric.
Plain-English summary
Cook Incorporated is recalling specific lots of the Rosen Curved Wire Guide, a surgical guidewire used in medical procedures. The affected devices were distributed nationwide in the United States and internationally.
The recall was initiated after Cook Medical identified that devices from the affected lots may have a complete breach of the chevron seal of the packaging. This packaging defect may compromise the sterility of the devices.
Affected product lots include THSCF-35-220-1.5-ROSEN, THSCF-35-80-1.5-ROSEN, THSCF-35-180-1.5-ROSEN, and THSCF-35-145-1.5-ROSEN. A total of 5,041 units were distributed in the US and 298 units outside the US.
Healthcare facilities and providers who have received affected devices should stop using them and contact Cook Incorporated for instructions on return or replacement.
The recalled product
- Product
- Rosen Curved Wire Guide, Guidewire Reference Part Number/GPN THSCF-35-220-1.5-ROSEN G01623 THSCF-35-80-1.5-ROSEN G01774 THSCF-35-180-1.5-ROSEN G01264 THSCF-35-145-1.5-ROSEN G01261
- 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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