Recall Z-0248-2007 ยท FSA Lift, Patient, Non-Ac-Powered
Arjo, Inc.
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
| Date | Dec 6, 2006 (initiated Oct 30, 2006) |
| Status | Terminated |
| Reason | The sling ropes were manufactured with insufficient rope length past the knot to prevent the knot from coming loose. |
| 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 | 15 kits |
| Distribution | Nationwide, including Florida, Illinois, Indiana, Iowa, Kansas, Massachusetts, New York, Tennessee, Virginia and Wyoming. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.