Cook Inc. Recalls Heavy Duty PTFE Wire Guides Due to Loading Error
Cook Inc. is recalling 146 Heavy Duty 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 could lead to patient injury (introduction of a stiff tip instead of a flexible one), but the source text does not report any actual injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Cook Inc. is recalling 146 units of Heavy Duty PTFE Wire Guides, identified by Global Product Numbers G14323 and G14260. The recall is due to a potential issue where the wire guide may be incorrectly loaded into the wire guide holder.
If the wire guide is loaded incorrectly, the stiff tip of the device may be introduced into the patient instead of the intended flexible tip. This defect poses a risk of injury to the patient during use.
The affected products were distributed domestically across the United States and internationally to numerous countries, including Australia, Canada, China, Germany, India, Japan, and the United Kingdom. Healthcare providers and facilities should stop using the affected wire guides and contact Cook Inc. for further instructions on how to return or dispose of the devices.
The recalled product
- Product
- Heavy Duty PTFE Wire Guide, Guidewire, Global Product Number G14323 G14260 G14260
- Manufacturer
- Cook Inc.
- Affected units
- 146
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 7875295 8481133 NS8481135
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.
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