Recall Z-1599-2018 ยท FPO Stretcher, Wheeled
Stryker Medical Division of Stryker Corporation
6381 M-1 Cot Fastener, catalog no. 6381000000
| Date | Mar 9, 2018 |
| Status | Terminated |
| Reason | The Operations Manual and Maintenance Manual are missing various warnings and contain incorrect information. |
| Root cause | Labeling Change Control |
| Action | On March 9, 2018, the recalling firm notified affected distributors of the issue via their electronic product field action management system, who in turn notified their customers through written communication. Customers were informed of the issue and instructed to do the following: 1. Locate the operations manual shipped with each unit listed on the attached business reply form and replace it with the corrected manual included with the letter. Dispose of the incorrect manual. 2. Return the enclosed business reply form to confirm receipt of this notification to productfieldaction@stryker.com |
| Quantity | 3 |
| Distribution | Product distributed to the Netherlands |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.