Device product

Quick Release Gait Belt, 60

Z-0055-2021

September 15, 2020

Class II

Product summary

Firm: Medline Industries Inc
Event: Event 86448
Status: Ongoing
Classification: Class II
Quantity: 13,500 units
Official record key: device-enforcement:Z-0055-2021

Official wording

Reason: The buckle on the Gait Belt may break due to degradation of the material due to exposure to gamma radiation.

Code information: Model: MDT821208NATM /503689 Lots: 33019040001, 33019090001 and 33019100001 Used in kits with model number: DYKF1045 Lots: 20EBB832 and 20EBM643.

Distribution pattern: Domestic Distribution Only: IL, MI

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

The buckle on the Gait Belt may break due to degradation of the material due to exposure to gamma radiation.