Z-0248-2007

Sling Rope/Connector Assembly Kits for the Sara and Sara Nova standing and raising aids; the kit is comprised...

Name: Z-0248-2007 Sling Rope/Connector Assembly Kits for the Sara and Sara Nova standing and raising aids; the kit is comprised...
Creator: Arjo, Inc.
Published: 2006-10-30
License: https://open.fda.gov/license/

Arjo, Inc. / initiated 2006-10-30 / Terminated / root cause: manufacturing process

FDA source

Arjo, Inc. began a recall of Sling Rope/Connector Assembly Kits for the Sara and Sara Nova standing and raising aids; the kit is comprised of 2 x 200 cm ropes, 2 knobs, 2 sling connectors... on 2006-10-30. The reason FDA records is "The sling ropes were manufactured with insufficient rope length past the knot to prevent the knot from coming loose". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0248-2007
Status: Terminated
Initiated: 2006-10-30
Posted: 2006-12-06
Terminated: 2008-01-18
Recalling firm: Arjo, Inc.
Product: Sling Rope/Connector Assembly Kits for the Sara and Sara Nova standing and raising aids; the kit is comprised of 2 x 200 cm ropes, 2 knobs, 2 sling connectors, 2 socket cap screws, 2 nylon nuts and 2 spacers; Arjo Inc., 50 N. Gary Avenue, Roselle, IL 60172; Model KS1006
Product code: FSA Lift, Patient, Non-Ac-Powered
Reason for recall: The sling ropes were manufactured with insufficient rope length past the knot to prevent the knot from coming loose.
Root cause tag: manufacturing process
FDA root cause: Other
Action: Arjo Inc. USA sent recall letters to the direct accounts on 10/30/06, informing them that affected rope kits were incorrectly assembled, and could lead to the rope separating from the cone-shaped knob and causing the patient to fall back from the lift. The letters listed the specific quantities, order numbers and dates for the kits shipped to the customer, and requested the removal from use and return of the affected rope kits. Replacement rope kits were sent with the recall letters. Any questions were directed to Arjo''s Quality Department at 1-800-323-1245, ext. 6140.
Quantity in commerce: 15 kits
Distribution: Nationwide, including Florida, Illinois, Indiana, Iowa, Kansas, Massachusetts, New York, Tennessee, Virginia and Wyoming.
Product codes and lots: Model KS1006, all kits shipped between July 2006 through September 2006

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)