Carry bar which is an accessory to a lift used for patients in hospitals and other facilities. R...

FDA Device Recall #Z-0728-2017 — Class II — August 30, 2016

Recall Summary

Recall Number Z-0728-2017
Classification Class II — Moderate risk
Date Initiated August 30, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm ErgoSafe Products, LLC (DBA) Prism Medical
Location Maryland Heights, MO
Product Type Devices
Quantity not greater than 17,964 units

Product Description

Carry bar which is an accessory to a lift used for patients in hospitals and other facilities. Recall impacts the following model numbers: 360741, 360750, 360751, 360755, 360755 Rev B, 360756, and 360757.

Reason for Recall

The black plastic puck on the carry bar is breaking resulting in potential for patient harm.

Distribution Pattern

Distributed US nationwide and to Canada, Japan, Australia, Thailand, Great Britain, and South Korea

Lot / Code Information

There are no lot numbers, serial numbers, or UPC codes, only the model numbers. Model numbers: 360741, 360750, 360751, 360755, 360755 Rev B, 360756, and 360757.

Other Recalls from ErgoSafe Products, LLC (DBA) Prism Me...

Recall # Classification Product Date
Z-1406-2017 Class II A-series lift - A625 Manual Part No. 324117. Pr... Jan 30, 2017
Z-1405-2017 Class II A-series lift - A625 Manual w/Load Cell & Wi-Fi... Jan 30, 2017
Z-0285-2016 Class II Prism Medical P-300 Portable Consumer Lift; PN ... Sep 8, 2015
Z-0284-2016 Class II Prism Medical C-300 Consumer Ceiling Lift; PN 3... Sep 8, 2015
Z-2269-2015 Class II Prism Medical P-440 Portable Ceiling Lift; PN 3... Jun 24, 2015

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.