Arjo, Inc. Sara Active Sling - Wide; item KKX00120.0 - models KA1231 (with safety) and KA1241; manufactured by Medibo Medical Products NV, Hanmont, Achel, Belgium, distributed by Arjo Inc., Roselle, IL 60172 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Sara Active Sling - Wide; item KKX00120.0 - models KA1231 (with safety) and KA1241; manufactured by Medibo Medical Products NV, Hanmont, Achel, Belgium, distributed by Arjo Inc., Roselle, IL 60172
Brand
Arjo, Inc.
Lot Codes / Batch Numbers
item KKX00120.0 - models KA1231 (with safety) and KA1241, and either the month ''09'', ''10'', ''11'' or ''12'' hole-punched in the third line ''M''.
Products Sold
item KKX00120.0 - models KA1231 (with safety) and KA1241, 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''.
Arjo, Inc. is recalling Sara Active Sling - Wide; item KKX00120.0 - models KA1231 (with safety) and KA1241; manufactured by due to There is the potential for the slings to come apart, potentially allowing injury to the patient.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There is the potential for the slings to come apart, potentially allowing injury to the patient.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026