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Terminated

Transfer/Gait Belt, Plastic, Wipeable, packaged in plastic bag, 36 plastic bags per box.

FDA Recall Z-0163-2018 · Posted None

Recalling FirmMedline Industries Inc
Recall StatusTerminated
Product CodeIKX
Date Initiated2017-08-10
Date Terminated2020-04-24
Product Quantity1,428 units total

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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