Trauma Stryker Medical Stretchers Model 1037 Intended to transport patients in a horizontal position
Stryker Medical Division of Stryker Corporation began a recall of Trauma Stryker Medical Stretchers Model 1037 Intended to transport patients in a horizontal position on . The reason FDA records is "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-2863-2011
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Stryker Medical
- Product
- Trauma Stryker Medical Stretchers Model 1037 Intended to transport patients in a horizontal position.
- Product code
- FPO Stretcher, Wheeled
- Reason for recall
- 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 tag
- manufacturing process
- FDA 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 of the letter was also included. For additional information call (269) 389-6604.
- Quantity in commerce
- 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.
- Product codes and lots
- Model: 1037 Lots: 1102035156, 1102035157, 1102034561, 1102034562, 1102034563, 1102034564, 1102034565, 1102034592, 1102034593, 1102034599 and 1102034600.
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