FDA Medical Device Recalls (openFDA)
Arjo, Inc.: Sling Rope/Connector Assembly Kits for the Sara Power standing and raising aids; the kit is comprised of 2 x 230 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 KS1019
- Recall number
- Z-0249-2007
- Recalling firm
- Arjo, Inc.
- Product
- Sling Rope/Connector Assembly Kits for the Sara Power standing and raising aids; the kit is comprised of 2 x 230 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 KS1019
- Status
- Terminated
- Initiated
- 2006-10-30
- Posted
- 2006-12-06
- Terminated
- 2008-01-18
- 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
- 13 kits
- Distribution
- Nationwide, including Florida, Illinois, Indiana, Iowa, Kansas, Massachusetts, New York, Tennessee, Virginia and Wyoming.
- Lot, serial or model codes
- Model KS1019, all kits shipped between July 2006 through September 2006
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FSA
- Firm FEI
- 1419652
- Firm city
- Roselle
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28