Recall Z-0510-2014 ยท MJN Catheter, Intravascular Occluding, Temporary
Stryker Neurovascular
Stryker brand COMPLIANT 5MM X 30MM, Catalog Number: M003SRC05300; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coil
| Date | Dec 13, 2013 (initiated Nov 4, 2013) |
| Status | Terminated |
| Reason | Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015. |
| Root cause | Software Manufacturing/Software Deployment |
| Action | Stryker Neurovascular sent an Urgent Medical Device Recall letter dated November 4, 2013, all affected users. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use and segregate the affected products. Customers with questions were instructed to contact via NeuroComplaints@stryker.com. Or Fax the response form to 1-800-876-4355. For questions regarding this recall call 510-413-2500. |
| Distribution | Worldwide Distribution - USa (nationwide) and Internationally to: Austria, Belgium, Czech Rep, Germany, France, Great Britain, Hungary, Italy, Lithuania, Netherlands, Norway, Poland, Slovakia, Spain, Turkey, Australia, Canada, Chile, Hong Kong, India, Korea, Malaysia, Russia and Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122576 | TRANSFORM OCCLUSION BALLOON CATHETER (COMPLIANT AND SUPER COMPLIANT Stryker Neurovascular, Jan 11, 2013 |