Cook Newton Wire Guide Recalls Due to Potential Sterility Compromise
Cook Incorporated is recalling certain Newton Wire Guide surgical guidewires because packaging seals 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 recall involving potential sterility compromise on surgical medical devices. No illnesses or injuries are mentioned in the recall notice, placing this in the 'risk-of-harm' category where injury has not yet been reported.
Plain-English summary
Cook Incorporated is recalling certain Newton Wire Guide surgical guidewires due to a packaging defect. The affected products are the LT Taper/10cm Distal Flexibility model guidewires with two specific model numbers and lot codes provided.
Cook Medical identified that devices from the affected lots may have a complete breach of the chevron seal in the packaging. This seal breach may compromise the sterility assurance of the devices.
The guidewires were distributed domestically nationwide and internationally. Patients and healthcare facilities that have received these devices should contact Cook Incorporated regarding this recall.
The recalled product
- Product
- Newton Wire Guide (LT Taper/10cm Distal Flexibility), Guidewire Reference Part Number/GPN: TSFNA-35-145 G00701 TSCFNA-35-145-3 G00561
- Manufacturer
- Cook Incorporated
- Affected units
- 42
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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