Recall Z-2863-2011 ยท FPO Stretcher, Wheeled
Stryker Medical Division of Stryker Corporation
Trauma Stryker Medical Stretchers Model 1037 Intended to transport patients in a horizontal position.
| Date | Jul 22, 2011 (initiated Jul 19, 2011) |
| Status | Terminated |
| Reason | The firm has determined that the brake rod assemblies of various stretchers that were built with a 5th wheel were manufactured with roll pins that did not meet the materials specifications. Some roll pins may have fractured during the assembly process and could fall out of the brake rod assemblies, rendering the brake or steer systems inoperable from certain pedals or causing a reduction in overa |
| Root cause | Nonconforming Material/Component |
| Action | Stryker Medical sent an "Urgent Medical Device Correction" dated July 19 ,2011 to all affected customers. The letter included; the name and model numbers of the stretchers, the reason for the correction and dates of manufacture. It contained the instructions to check the braking system and if found to be inoperable, to remove it from service, and if operable to check prior to each use. Also, information regarding contacting the recipients of any loaned or sold stretchers to relay the information in the letter and Medwatch reporting information. A self addressed postcard to confirm receipt |
| Quantity | 11 |
| Distribution | Worldwide Distribution: Nationwide (USA) including the states of NY, MI, LA and CA ,and the countries of Canada, China, Spain, Japan, Korea, United Kingdom, South Africa. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.