Z-0424-2007

Sara Active Sling - Narrow; item KKX053850.0 - models KA1230 (with safety) and KA1240; manufactured by Medibo...

Name: Z-0424-2007 Sara Active Sling - Narrow; item KKX053850.0 - models KA1230 (with safety) and KA1240; manufactured by Medibo...
Creator: Arjo, Inc.
Published: 2007-01-09
License: https://open.fda.gov/license/

Arjo, Inc. / initiated 2007-01-09 / Terminated

FDA source

Arjo, Inc. began a recall of Sara Active Sling - Narrow; item KKX053850.0 - models KA1230 (with safety) and KA1240; manufactured by Medibo Medical Products NV, Hanmont, Achel, Belgium... on 2007-01-09. The reason FDA records is "There is the potential for the slings to come apart, potentially allowing injury to the patient". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0424-2007
Status: Terminated
Initiated: 2007-01-09
Posted: 2007-02-15
Terminated: 2008-09-02
Recalling firm: Arjo, Inc.
Product: Sara Active Sling - Narrow; item KKX053850.0 - models KA1230 (with safety) and KA1240; manufactured by Medibo Medical Products NV, Hanmont, Achel, Belgium, distributed by Arjo Inc., Roselle, IL 60172
Product code: FSA Lift, Patient, Non-Ac-Powered
Reason for recall: There is the potential for the slings to come apart, potentially allowing injury to the patient.
FDA root cause: Other
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: 66 slings
Distribution: Nationwide
Product codes and lots: item KKX053850.0 - models KA1230 (with safety) and KA1240, 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''.

Product code FSA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)