Cook Incorporated Recalls Guidewire Due to Packaging Seal Breach
Cook Incorporated is recalling Heavy Double Flexible Tipped Wire Guide devices due to potential packaging seal breach that may compromise sterility. Affected products were distributed domestically 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: FDA Class II recall of medical device with packaging breach that may compromise sterility, creating infection risk. No illnesses or injuries reported, placing this at High (3) per rubric criterion of risk-of-harm without reported injury.
Plain-English summary
Cook Incorporated is recalling specific lots of Heavy Double Flexible Tipped Wire Guide devices (reference numbers THDOC-35-60-0-3 G11949, C-HDOC-18-40-0-2 G09201, and C-THDOC-18-40-0-2-HTS G26925) due to packaging defects.
Cook Medical identified that the chevron seal of the packaging on these affected devices may have a complete breach. A compromised seal can affect the sterility of the medical device, potentially exposing patients to contamination risk.
The recalled devices were distributed domestically throughout the United States and internationally. Patients who received these guidewires and healthcare providers should discontinue use of devices from affected lots and contact Cook Incorporated for instructions regarding return, replacement, or disposal.
Consumers and patients should contact their healthcare provider if they have received a device from an affected lot. Healthcare facilities should review their inventory and quarantine devices matching the affected lot numbers.
The recalled product
- Product
- Heavy Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN: THDOC-35-60-0-3 G11949 C-HDOC-18-40-0-2 G09201 C-THDOC-18-40-0-2-HTS G26925
- Manufacturer
- Cook Incorporated
- Affected units
- 25
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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