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U.S. Department of Health and Human Services

Class 2 Device Recall Alimed Gait Belt (Transfer Aid)

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  Class 2 Device Recall Alimed Gait Belt (Transfer Aid) see related information
Date Initiated by Firm October 30, 2008
Date Posted January 22, 2009
Recall Status1 Terminated 3 on September 09, 2011
Recall Number Z-0599-2009
Recall Event ID 50127
Product Classification Transfer Aid - Product Code IKX
Product Alimed Gait Belt (Transfer Aid) Antimicrobial Plastic Buckle, 70"
Model: 72109
Code Information Lot Numbers: Y3356 and Y3170.
Recalling Firm/
Manufacturer		 AliMed Corporation
297 High St
Dedham MA 02026
For Additional Information Contact SAME
781-329-2900 Ext. 126
Manufacturer Reason
for Recall		 Misassembled gait (transfer aid) belt.
FDA Determined
Cause 2		 Employee error
Action Alimed notified accounts via U.S. Postal Service (Return Receipt Requested) with a Recall Notice dated 10/30/2008 and instructs users to review their records and notify all users to whom the product may have been issued. If any of the product has been issued outside of their facility, customers are to forward the correspondence to them in it's entirety. Customers are to complete the enclosed form for return of their product (new or used) and the issuance of replacement product or credit.
Quantity in Commerce 993 units total
Distribution Nationwide Distribution
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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