FDA Medical Device Recalls (openFDA)
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 number
- Z-0425-2007
- Recalling firm
- Arjo, Inc.
- 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
- Status
- Terminated
- Initiated
- 2007-01-09
- Posted
- 2007-02-15
- Terminated
- 2008-09-02
- Reason
- There is the potential for the slings to come apart, potentially allowing injury to the patient.
- 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
- 16 slings
- Distribution
- Nationwide
- Lot, serial or model codes
- 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''.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FSA
- Firm FEI
- 1419652
- Firm city
- Roselle
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28