Class I — Cook Inc.
| Recalling firm | COOK, INC. |
|---|---|
| Registered facility | View this company's 5 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | Potential coating contamination with glass particles. |
| 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; HPWA-35-150, G56173; HPWA-35-180, G56174; HPWA-18-180, G56160; HPWAS-35-150, G56176; 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… |
| Quantity | 8,750 devices were distributed in commerce |
| Distribution | Worldwide distribution. US (nationwide), Australia, Austria, Belgium, Canada, China, Czech Republic, France, Germany, Hong Kong, Hungary, Italy, Jordan, Korea, Spain, South Africa, Taiwan, Turkey, and United Kingdom |
| Initiated | 2016-06-24 |
| Classified | 2016-08-25 |
| Terminated | 2017-11-01 |
| Recall number | Z-2537-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Cook Inc. (Z-2537-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74561/
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