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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Medical Stretcher Model 748 Transport

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  Class 2 Device Recall Stryker Medical Stretcher Model 748 Transport see related information
Date Initiated by Firm July 19, 2011
Date Posted August 03, 2011
Recall Status1 Terminated 3 on August 28, 2013
Recall Number Z-2922-2011
Recall Event ID 59214
Product Classification Stretcher, wheeled, powered - Product Code INK
Product Stryker Medical Stretcher Model 748 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.
Code Information Lots 1104030025, 1104030026, 1104030027, 1104030028, 1104030055, 1104030210 and 1104030203.
Recalling Firm/
Manufacturer		 Stryker Medical Division of Stryker Corporation
3800 East Centre Ave.
Portage MI 49002
For Additional Information Contact Matt Jordan
269-389-6604
Manufacturer 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.
FDA Determined
Cause 2		 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 7
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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