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Terminated

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

FDA Recall Z-0425-2007 · Posted 2007-02-15

Recalling FirmArjo, Inc.
Recall StatusTerminated
Product CodeFSA
Date Initiated2007-01-09
Date Terminated2008-09-02
Product Quantity16 slings

Reason for Recall

There is the potential for the slings to come apart, potentially allowing injury to the patient.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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