Quick Release Gait Belt, 60

FDA Device Recall #Z-0055-2021 — Class II — September 15, 2020

Recall Summary

Recall Number Z-0055-2021
Classification Class II — Moderate risk
Date Initiated September 15, 2020
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Medline Industries Inc
Location Northfield, IL
Product Type Devices
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

Lot / Code Information

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

Other Recalls from Medline Industries Inc

Recall # Classification Product Date
Z-0358-2022 Class II EVLP Convenience Pack/Kit Oct 27, 2021
Z-0359-2022 Class II Neuro Convenience Kit Oct 27, 2021
Z-0360-2022 Class II Major Vascular CDS Convenience Kit Oct 27, 2021
Z-0362-2022 Class II Bedside PICC CDS Convenience Kit Oct 27, 2021
Z-0361-2022 Class II Venous Access Pack-LF Convenience Kit Oct 27, 2021

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.