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
FDA Recall Z-0248-2007 · Posted 2006-12-06
Recalling FirmArjo, Inc.
Recall StatusTerminated
Product CodeFSA
Date Initiated2006-10-30
Date Terminated2008-01-18
Product Quantity15 kits
Reason for Recall
The sling ropes were manufactured with insufficient rope length past the knot to prevent the knot from coming loose.
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide, including Florida, Illinois, Indiana, Iowa, Kansas, Massachusetts, New York, Tennessee, Virginia and Wyoming.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.