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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker stretcher

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 Class 2 Recall
Stryker stretcher
see related information
Date Posted September 21, 2007
Recall Status1 Terminated on June 11, 2008
Recall Number Z-1009-2007
Recall Event ID 37978
Product Classification Stretcher, Wheeled - Product Code FPO
Product Stryker Medical -Wheeled Electric Stretcher, Model 1550 (with and without scales)
Code Information Serial numbers 0508083666, 0509069531, 0509069532, 0509069533, 0509069534, 0509069535, 0509069542, 0509069564, 0509069565, 0509069566, 0509069567, 0509069568, 0509069569, 0509069588, 0509069589, 0509069590, 0509069591, 0509069662, 0509069663, 0509069664, 0509069665, 0509069693, 0509069694, 0509069695, 0509069696, 0509069697, 0509069698, 0509069699, 0509069700, 0509069701, 0509069770, 0509069771, 0509069772, 0509069773, 0509069774, 0509069775, 0509069776, 0509069777, 0509069778, 0509069795, 0509069796, 0509069806, 0509069816, 0509069817, 0509069818, 0509069819, 0509069832, 0509069835, 0509069836, 0509069837, 0509069838, 0509069839, 0509069840, 0509069841, 0509069848, 0509069849, 0509069873, 0509069874, 0509069875, 0509069876, 0509069877, 0510071024, 0510071025, 0510071026, 0510071032, 0510071033, 0510071034, 0510071035, 0510071036, 0510071037, 0510071038, 0510071039, 0510071040, 0510071041, 0510071042, 0510071043, 0510071154, 0510071155, 0510071156, 0510071157, 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Recalling Firm/
Manufacturer
Stryker Medical Div. of Stryker Corporation
3800 E. Centre Ave.
Portage, Michigan 49002
For Additional Information Contact Mike Mazelin
800-669-4968 Ext. 6687
Manufacturer Reason
for Recall
The internal power cord may become damaged due to wear and, if this occurs, a shock hazard exists.
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Process Change Control
Action Consignees were notified of the problem via letter dated 5/7/07 instructing them to immediately unplug the affected stretchers with scales, affix a warning label enclosed with the letter to the power cord of stretchers with scales, and that they will be contacted so that the firm can schedule a visit to upgrade all affected stretchers. A second notification letter was issued on August 7, 2007 to cover all 1550 stretchers with and without scales.
Quantity in Commerce 1,048 (1009 in the U.S. plus 39 international)
Distribution Worldwide: USA, Latin America, Mexico and Spain.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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