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U.S. Department of Health and Human Services

Class 2 Device Recall ReTurn 7400/7500

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 Class 2 Device Recall ReTurn 7400/7500see related information
Date Initiated by FirmApril 15, 2014
Create DateOctober 24, 2016
Recall Status1 Terminated 3 on December 13, 2016
Recall NumberZ-0303-2017
Recall Event ID 75404
Product Classification Aid, transfer - Product Code IKX
ProductReTurn 7500/7500 Aid, transfer
Code Information Model # 7400, 7500 and 7322 (spare part) Serial # 373317697270501334, 373317697270501430, 073317697400500012, 073317697400500057
Recalling Firm/
Manufacturer		 Handicare USA, Inc.
2201 Hangar Pl
Ste 200
Allentown PA 18109-9342
For Additional Information Contact
717-733-1444
Manufacturer Reason
for Recall		During the period of April 2009  May 2011, Handicare AB used a wing handle in which the screw and handle, after repeated tightening, may slide apart. This causes a small amount of play in the attachment of the ladder, which in turn results in high load at the attachment holes of the ladder. Eventually, this may cause mechanical fatigue in the material of the ladder.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionHandicare sent a Field Safety notice dated April 21, 2014, to all affected customers. The notification instructed customers to examine the affected ReTurn units for signs of wear and to complete the response form that was mailed with the customer notification letter indicating whether additional parts were required to complete the field correction. For further questions, please call (717) 733-1444.
Quantity in Commerce29 units , plus 47 wing handles were shipped as spare parts
DistributionUS Distribution to the states of : NY, NJ, NV, NE, IL, CT, PA and ME
Total Product Life CycleTPLC 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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