Stryker brand EXCELSIOR 1018 PRE-SHAPED 45 150CM, Catalog Number: M0031441900; Product is manufactured by Stryker Neurov
FDA device recall Z-0494-2014 · posted 2013-12-13 · Terminated
Recall details
- Recalling firm
- Stryker Neurovascular
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Software Manufacturing/Software Deployment
- Status
- Terminated
- Product code
- DQY
- Distribution
- Worldwide Distribution - USa (nationwide) and Internationally to: Austria, Belgium, Czech Rep, Germany, France, Great Britain, Hungary, Italy, Lithuania, Netherlands, Norway, Poland, Slovakia, Spain,
- Date initiated
- 2013-11-04
- Date posted
- 2013-12-13
- Date terminated
- 2014-08-27
- Location
- Fremont, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EXCELSIOR 1018 AND SL-10 MICROCATHETERS (K042568) | Boston Scientific Corp | 2004-10-15 |