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U.S. Department of Health and Human Services

Class 2 Device Recall Transfer/Gait Belt

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  Class 2 Device Recall Transfer/Gait Belt see related information
Date Initiated by Firm August 10, 2017
Create Date November 21, 2017
Recall Status1 Terminated 3 on April 24, 2020
Recall Number Z-0164-2018
Recall Event ID 78363
Product Classification Aid, transfer - Product Code IKX
Product Transfer/Gait Belt, Plastic, Wipeable, packaged in plastic bag, 36 plastic bags per box.
Code Information Model No. MDT821203WPL, all lot numbers that begin with 90317XXXXXX. "X" represents any number.
Recalling Firm/
Manufacturer		 Medline Industries Inc
Three Lakes Drive
Northfield IL 60093
For Additional Information Contact Brad Schmidt
866-359-1704
Manufacturer Reason
for Recall		 The locking mechanism on the belt may fail to secure/hold the strap when in locked position potentially allowing the belt strap to slip through the buckle.
FDA Determined
Cause 2		 Device Design
Action Medline Industries sent an Immediate Action Required Recall Notification letter via First Class mail dated August 10, 2017. The recall was later expanded and customers were notified via letter of the additional lots dated August 21, 2017. Instructions in both letters included to check inventory and quarantine any affected product, complete and return the included response form, coordinate the return of all affected product, and notify customers if the product was further distributed. Additional customers were identified and notified of the recall via the same process on September 19th, 2017. For further questions, please call (866) 359-1704.
Quantity in Commerce 1,428 units total
Distribution USA (nationwide) Distribution to the states of : AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NH, NV, NY, OH , OK, OR, PA, RI, SC, TN, TX, VA, VT, WA, WI and WV.
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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