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Class 2 Device Recall Stryker Medical StairPRO StairChair |
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Date Initiated by Firm |
November 18, 2008 |
Date Posted |
February 04, 2009 |
Recall Status1 |
Terminated 3 on October 27, 2010 |
Recall Number |
Z-0648-2009 |
Recall Event ID |
50178 |
Product Classification |
patient transport device, - Product Code FPP
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Product |
Stryker Medical Stair-PRO Stair-Chair with wheels, patient transport device, Model 6251. |
Code Information |
Serial numbers 080940844, 080940845, 080940858, 080940819, 080940820 and 080940640. |
Recalling Firm/ Manufacturer |
Stryker Medical Div. of Stryker Corporation 3800 E. Centre Ave. Portage MI 49002
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For Additional Information Contact |
800-869-0770 Ext. 6902
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Manufacturer Reason for Recall |
Handle could come off. The bolts may back out over time, resulting in a risk of dropping the patient and/or injury to transport personnel, a delay in medical treatment, or a delay in evacuation.
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FDA Determined Cause 2 |
Process control |
Action |
Consignees were notified by Urgent Medical Device Correction letter dated 11/18/08 and given the serial numbers of their units, an upgrade kit and instructions for performing replacement of the bolts. Consignees were informed Stryker will perform the upgrade if requested. |
Quantity in Commerce |
6 |
Distribution |
Worldwide Distribution: USA, India, Netherlands 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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