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U.S. Department of Health and Human Services

Class 2 Device Recall Sling Rope/Connector Assembly Kits

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  Class 2 Device Recall Sling Rope/Connector Assembly Kits see related information
Date Initiated by Firm October 30, 2006
Date Posted December 06, 2006
Recall Status1 Terminated 3 on January 18, 2008
Recall Number Z-0249-2007
Recall Event ID 36680
Product Classification lift - Product Code FSA
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
Code Information Model KS1019, all kits shipped between July 2006 through September 2006
Recalling Firm/
Manufacturer		 Arjo, Inc.
50 Gary Ave Ste A
Roselle IL 60172-1684
For Additional Information Contact Ms. Traci Giovenco
800-323-1245
Manufacturer Reason
for Recall		 The sling ropes were manufactured with insufficient rope length past the knot to prevent the knot from coming loose.
FDA Determined
Cause 2		 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 13 kits
Distribution Nationwide, including Florida, Illinois, Indiana, Iowa, Kansas, Massachusetts, New York, Tennessee, Virginia and Wyoming.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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