Cook Inc. Recalls Bentson PTFE Wire Guides Due to Loading Error
Cook Inc. is recalling Bentson PTFE Wire Guides because they may be incorrectly loaded, causing the stiff tip to be introduced into patients instead of the flexible tip.
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: The recall involves a medical device defect that poses a risk of harm to patients by introducing a stiff tip instead of a flexible one, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Cook Inc. is recalling 1,079 units of Bentson PTFE Wire Guides, identified by Global Product Numbers G14589 and G14590. The recall involves specific lot codes including 7832513, 7832514, 8062406, 8062407, 8065988, 8065989, 8065992, 8404354, 8404355, 8547811, and 8069648.
The recall was initiated because the wire guide may be incorrectly loaded into the wire guide holder. This error can lead to the stiff tip of the wire guide being introduced into the patient instead of the intended flexible tip. The products were distributed domestically across the United States and internationally to numerous countries including Australia, Canada, China, France, Germany, India, Japan, and the United Kingdom.
Healthcare providers and facilities should check their inventory for the affected lot codes and stop using these devices. Consumers are advised to contact their healthcare provider if they have had a procedure involving these specific wire guides to discuss any potential concerns.
The recalled product
- Product
- Bentson PTFE Wire Guide, Guidewire, Global Product Number G14589, G14590
- Manufacturer
- Cook Inc.
- Affected units
- 1,079
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 20 recalled by Cook Inc. 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 20 products in this recall →Related recalls
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