Recall Z-0426-2007 ยท FSA Lift, Patient, Non-Ac-Powered
Arjo, Inc.
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
| Date | Feb 15, 2007 (initiated Jan 9, 2007) |
| Status | Terminated |
| 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. 614 |
| Quantity | 13 slings |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.