Cook Inc. Recalls Roadrunner Uniglide Hydrophilic Wire Guides Due to Glass Contamination
Cook Inc. is recalling Roadrunner Uniglide Hydrophilic Wire Guides because they may be contaminated with glass particles. The recall covers 8,750 devices distributed 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: The recall involves a medical device with a potential for physical injury (glass particles) but the source text does not report any illnesses or injuries, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Cook Inc. is recalling the Roadrunner Uniglide Hydrophilic Wire Guide, a medical device used with vascular catheters. The recall is being conducted because the devices may be contaminated with glass particles. The affected products are constructed from a steerable, metallic core with a polymer coating and a hydrophilic coating applied over a radiopaque polymer jacket.
A total of 8,750 devices were distributed in commerce. The distribution was worldwide, including the United States (nationwide), Australia, Austria, Belgium, Canada, China, the Czech Republic, France, Germany, Hong Kong, Hungary, Italy, Jordan, Korea, Spain, South Africa, Taiwan, Turkey, and the United Kingdom. The recall includes specific catalog numbers and GPNs, as well as a list of specific lot numbers.
Healthcare providers and consumers should stop using the affected devices and contact Cook Inc. for further instructions or a replacement. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- Roadrunner Uniglide Hydrophilic Wire Guide, Catalog Numbers and GPN: HPWA-18-260, G30489; HPWA-18-320, G30490; HPWA-25-260, G30491; HPWA-35-260, G30492; HPWAS-35-260, G30506; HPW-35-150, G56149; HPW-35-180, G56150; HPWS-35-150, G56152; HPWS-35-180, G56153; HPWA-35-80, G56172; HPW
- Manufacturer
- Cook Inc.
- Affected units
- 8,750
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 (20)
- Roadrunner Uniglide Hydrophilic Wire Guide
- Catalog Numbers and GPN: HPWA-18-260
- G30489
- HPWA-18-320
- G30490
- HPWA-25-260
- G30491
- HPWA-35-260
- G30492
- HPWAS-35-260
- G30506
- HPW-35-150
- G56149
- HPW-35-180
- G56150
- HPWS-35-150
- G56152
- HPWS-35-180
- G56153
- HPWA-35-80
Distribution
Distributed nationwide across the United States.
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