Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER — Class II medical device recall Z-1716-2022
Ongoing recall by Cook Incorporated, reported 2022-09-21, distributed nationwide. Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration tes
| Recall number | Z-1716-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Incorporated, Bloomington, IN, United States |
| Recall initiated | 2022-07-19 |
| Classified | 2022-09-09 |
| Reported by FDA | 2022-09-21 |
| Distributed | Nationwide (US) |
| Quantity | 189 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00827002561755 |
| Lot numbers | 14174876, 14174880, NS14104906, NS14173970, NS14173971 |
| Model numbers | HPWAS-35-80 |
Product
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-80 ORDER NUMBER (GPN): G56175. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Reason for recall
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1716-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.