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Recall Observatory FDA recall evidence

Device product

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

Z-0163-2018

August 10, 2017

Class II

Product summary

Firm
Medline Industries Inc
Event
Event 78363
Status
Terminated
Classification
Class II
Quantity
1,428 units total
Official record key
device-enforcement:Z-0163-2018

Official wording

Reason: 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.

Code information: Model No. MDT821203WP, all lot numbers that begin with 90317XXXXXX. "X" represents any number.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.