Cook Inc. Recalls Fixed Core Straight Safety Wire Guide
Cook Inc. is recalling 15 units of Fixed Core Straight Safety Wire Guides because they may be incorrectly loaded, causing the stiff tip to be introduced into patients.
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 physical harm to patients (introduction of a stiff tip) but does not report specific injuries or fatalities, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Cook Inc. is recalling 15 units of the Fixed Core Straight Safety Wire Guide, Global Product Number G14285. The recall is due to a risk that the wire guide may be incorrectly loaded into the wire guide holder. This error could lead to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
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. The recall number is Z-0960-2020.
Healthcare providers and facilities should stop using the affected wire guides and contact Cook Inc. for further instructions on handling the recalled units.
The recalled product
- Product
- Fixed Core Straight Safety Wire Guide, Guidewire, Global Product Number G14285
- Manufacturer
- Cook Inc.
- Affected units
- 15
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)
- 7971639
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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