Reported Aug 31, 2016 · Terminated
Roadrunner Uniglide Hydrophilic Wire Guide, Catalog Numbers and GPN: HPWA-18-260, G30489; HPWA-18-320, G30490;…
Cook Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cook Inc. · 750 N Daniels Way · Bloomington, IN · 47404-9120
Is this the product you have?
15 of 15 products
| # | Product as published |
|---|---|
| 1 | Roadrunner Uniglide Hydrophilic Wire Guide, Catalog Numbers and GPN: HPWA-18-260, G30489 |
| 2 | HPWA-18-320, G30490 |
| 3 | HPWA-25-260, G30491 |
| 4 | HPWA-35-260, G30492 |
| 5 | HPWAS-35-260, G30506 |
| 6 | HPW-35-150, G56149 |
| 7 | HPW-35-180, G56150 |
| 8 | HPWS-35-150, G56152 |
| 9 | HPWS-35-180, G56153 |
| 10 | HPWA-35-80, G56172 |
| 11 | HPWA-35-150, G56173 |
| 12 | HPWA-35-180, G56174 |
| 13 | HPWA-18-180, G56160 |
| 14 | HPWAS-35-150, G56176 |
| 15 | HPWAS-35-180, G56177. Used with vascular catheter. Roadrunner UniGlide Hydrophilic Wire Guide is constructed from a steerable, metallic core with a polymer coating. A hydrophilic coating is applied over the radiopaque polymer jacket. Sterile- Individual product is packaged in a Tyvek-film sterilizable outer pouch and boxed in a quantity of five. |
- Amount recalled
- 8,750 devices were distributed in commerce
This recall covers 15 products
The agency filed one notice per product. You are reading one of them; the other 14 are below.
2 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Potential coating contamination with glass particles.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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