Product Safety Recalls

Product Recall Tracker

Cook Incorporated Recall 90710

Description: Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-18-150 ORDER NUMBER (GPN):G56161. For vascular catheter positioning and exchange in diagnostic and interventional procedures.

Cook Incorporated Recall 90710 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1711-2022
Event ID90710
Event DescriptionRoadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-18-150 ORDER NUMBER (GPN):G56161. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Product TypeDevices
DistributionNationwide Foreign: AR AT AU BE BG CA CA CH CL CN CZ DE DK ES FR GB GR GU HU IL IT JO JP KR KW MX MY NC NL PE PL PR PT PY RU SE SI TR UY ZA
Quantity85 units
Recall ReasonProduct 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.
Device Classification20220921
Device Code InfoUDI-DI: (01)00827002561618- Lot Numbers: 14095646, 14174879
Center Classification Date20220909
Recall Initiation Date20220719
Recalling FirmCook Incorporated
Initial Notification Letter
Similar To

© 2022 Recall.Report / Contact / Privacy Policy

This site's data is aggregated programmatically and provided "as is" without any representations or warranties, express or implied.
Recall.report is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way.