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U.S. Department of Health and Human Services

Class 2 Device Recall Sara Active Sling Standard

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 Class 2 Recall
Sara Active Sling Standard
see related information
Date Posted February 15, 2007
Recall Status1 Terminated on September 02, 2008
Recall Number Z-0426-2007
Recall Event ID 37085
Product Classification Lift, Patient, Non-Ac-Powered - Product Code FSA
Product Sara Active Sling - Standard; item KK53210.0 - model KA1210 (with safety); manufactured by Medibo Medical Products NV, Hanmont, Achel, Belgium, distributed by Arjo Inc., Roselle, IL 60172
Code Information item KK53210.0 - model KA1210 (with safety), with production dates of September 2006 through December 2006. The tag on the sling will state the item number and have the year ''06'' hole-punched in the top line ''Y'', and either the month ''09'', ''10'', ''11'' or ''12'' hole-punched in the third line ''M''.
Recalling Firm/
Manufacturer
Arjo, Inc.
50 Gary Ave Ste A
Roselle, Illinois 60172-1684
For Additional Information Contact Ms. Traci Giovenco
800-323-1245
Manufacturer Reason
for Recall
There is the potential for the slings to come apart, potentially allowing injury to the patient.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Arjo sent Urgent Device Field Correction Recall Notice letters dated 1/9/07 via FedEx to the end user accounts who received the affected slings, advising them of the potential for the slings to come apart. They were instructed to remove the affected slings from use and replace them with the slings enclosed with the letter, complete the enclosed customer response form, and return the form and the original recalled slings, using the pre-paid call tag provided. If they have any questions or require additional, they were instructed to contact the Arjo Quality Department at 800-323-1245, ext. 6140.
Quantity in Commerce 13 slings
Distribution Nationwide
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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