Stryker Medical Stretcher Model 747 Transport A wheeled stretcher consists of a platform mounted on a wheeled...
Stryker Medical Division of Stryker Corporation began a recall of Stryker Medical Stretcher Model 747 Transport A wheeled stretcher consists of a platform mounted on a wheeled frame that is designed to transport patients in a... on . The reason FDA records is "Stryker Medical has determined that some Prime Brake Pad Assembly components were manufactured with brake shoes that did not meet specifications. Accordingly some brake shoes used within the Prime Brake Pad Assembly may...". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-2921-2011
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Stryker Medical
- Product
- Stryker Medical Stretcher Model 747 Transport A wheeled stretcher consists of a platform mounted on a wheeled frame that is designed to transport patients in a horizontal position. The device has siderails and supports for fluid infusion equipment.
- Product code
- INK Stretcher, Wheeled, Powered
- Reason for recall
- Stryker Medical has determined that some Prime Brake Pad Assembly components were manufactured with brake shoes that did not meet specifications. Accordingly some brake shoes used within the Prime Brake Pad Assembly may wear prematurely, over the life of the product. Reduced braking force may result in a patient fall or caregiver muscle strain, either of which may require medical intervention.
- Root cause tag
- manufacturing process
- FDA root cause
- Nonconforming Material/Component
- Action
- Stryker Medical sent an "URGENT- MEDICAL DEVICE CORRECTION" letter dated July 18, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to locate the affected stretchers and to test the brakes. If the brakes are found to be inoperable, customers are instructed to remove the stretchers from service and contact the firm at 800-STRYKER, option 3. Additionally, customers are instructed not to put the stretchers back in service until they are repaired by the firm's field service representative. For units with properly functioning brakes, the letter also instructs the user to test the brakes before each use until the unit has been serviced. A post card was enclosed to confirm receipt of the letter. Questions or concerns may be addressed by calling Stryker at 269-389-6604.
- Quantity in commerce
- 26 units
- Distribution
- Worldwide Distribution-USA (nationwide) including the states of AL, CA, FL, GA, HI, IL, MA, MN, MO, NH, NJ, NV, NY, PA, RI, TX, UT, and VA and the country of THE NETHERLANDS.
- Product codes and lots
- Lots 1104030063, 1104030030, 1104030036, 1104030037, 1104030038, 1104030039, 1104030040, 1104030041, 1104030042, 1104030043, 1104030044, 1104030045, 1104030062 and 1104030061.
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