Z-0055-2021 Class II Ongoing
FDA device recall Z-0055-2021 was initiated by Medline Industries Inc on September 15, 2020 and is designated Class II. Reason for recall: The buckle on the Gait Belt may break due to degradation of the material due to exposure to gamma radiation. The recall status is ongoing. Affected quantity: 13,500 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 14, 2020
- Initiation Date
- September 15, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13,500 units
Product Description
Quick Release Gait Belt, 60
Reason for Recall
The buckle on the Gait Belt may break due to degradation of the material due to exposure to gamma radiation.
Distribution Pattern
Domestic Distribution Only: IL, MI
Code Information
Model: MDT821208NATM /503689 Lots: 33019040001, 33019090001 and 33019100001 Used in kits with model number: DYKF1045 Lots: 20EBB832 and 20EBM643.