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Class 2 Device Recall Stryker stretcher, Model 1509. |
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Date Initiated by Firm |
November 15, 2004 |
Date Posted |
November 10, 2007 |
Recall Status1 |
Terminated 3 on October 27, 2010 |
Recall Number |
Z-0236-2008 |
Recall Event ID |
37214 |
Product Classification |
Stretcher - Product Code FPO
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Product |
Stryker Renaissance Series/Advantage Series PACU wheeled stretcher, Model 1509, Stryker Medical, Portage, MI 49002
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Code Information |
All stretchers with serial numbers beginning with 0309 through 0505. |
Recalling Firm/ Manufacturer |
Stryker Medical Div. of Stryker Corporation 3800 E. Centre Ave. Portage MI 49002
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For Additional Information Contact |
800-669-4968 Ext. 6689
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Manufacturer Reason for Recall |
The brake cams may crack or develop excessive wear, resulting in the brakes not locking the wheels, or the stretcher not being locked firmly in position.
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FDA Determined Cause 2 |
Component change control |
Action |
The firm issued an Urgent Medical Device Correction Letter dated 9/24/07, to each consignee informing them of the problems, that the brakes on each affected stretcher needed to be inspected/tested and removed from service if brake problems were discovered, and that a Stryker service representative would be in contact to replace the brakes. |
Quantity in Commerce |
81,367 (61,708 U.S. and 19,569 ex-U.S.) for all models. |
Distribution |
Worldwide-USA, Argentina, Australia, Brazil, Canada, Chile, China, Dubai, France, India, Italy, Japan, Germany, Greece, Hong Kong, Korea, Latin America, Malaysia, Mexico, Netherlands, Poland, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, and United Kingdom. |
Total Product Life Cycle |
TPLC Device Report
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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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