Sling Rope/Connector Assembly Kits for the Sara and Sara Nova standing and raising aids; the kit is comprised of 2 x 200

FDA device recall Z-0248-2007 · posted 2006-12-06 · Terminated

Recall details

Recalling firm

Arjo, Inc.

Reason for recall

The sling ropes were manufactured with insufficient rope length past the knot to prevent the knot from coming loose.

Action taken

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

Status

Terminated

Product code

FSA

Quantity affected

15 kits

Distribution

Nationwide, including Florida, Illinois, Indiana, Iowa, Kansas, Massachusetts, New York, Tennessee, Virginia and Wyoming.

Date initiated

2006-10-30

Date posted

2006-12-06

Date terminated

2008-01-18

Location

Roselle, IL