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.
What this means for you
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
- Hazard
- sterility-compromise
- infection-risk
Distribution
Distributed nationwide across the United States.
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