Recall Z-2537-2016 ยท DQX Wire, Guide, Catheter
Cook Inc.
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 vasc
| Date | Aug 25, 2016 (initiated Jun 24, 2016) |
| Status | Terminated |
| Reason | Potential coating contamination with glass particles. |
| Root cause | Material/Component Contamination |
| Action | Cook Inc. initiated a voluntary recall of the Roadrunner UniGlide Hydrophilic Wire Guides on June 24, 2016 via courier due to the potential for the device to be contaminated with glass particles. The firm issued a press release dated August 12, 2016. Customers were asked to take the following actions: 1. Examine inventory immediately to determine if you have affected products and quarantine affected products. 2. Return affected products to Stericycle Expert Solutions (a third-party recall administration service provider). Use the enclosed label and a copy of the Acknowledgement and Receip |
| 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 |
| FDA record | Open on fda.gov |