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

FDA device recall Z-0424-2007 · posted 2007-02-15 · Terminated

Recall details

Recalling firm

Arjo, Inc.

Reason for recall

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

Action taken

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

Status

Terminated

Product code

FSA

Quantity affected

66 slings

Distribution

Nationwide

Date initiated

2007-01-09

Date posted

2007-02-15

Date terminated

2008-09-02

Location

Roselle, IL