FDA Device recall Z-1710-2022
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPW-35-150 ORDER NUMBER (GPN):G56149
- FDA Device
- Class II
- ongoing
- Published 2022-09-21
On 2022-09-21 the FDA classified a Class II recall of Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPW-35-150 ORDER NUMBER (GPN):G56149 by Cook, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1710-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-07-19 |
| Published | 2022-09-21 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Cook |
| Distribution | US |
Product
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPW-35-150 ORDER NUMBER (GPN):G56149. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Reason
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.
Identifiers
| code_info | UDI-DI: (01)00827002561496- Lot Numbers: 14070921, 14108915, 14108916, 14129152, 14141997, 14170230 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1710-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.