Ferno PROFlexx¿ Model 28Z Chair Cot

FDA Device Recall #Z-1827-2017 — Class II — March 8, 2017

Recall Summary

Recall Number Z-1827-2017
Classification Class II — Moderate risk
Date Initiated March 8, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Ferno-Washington Inc
Location Wilmington, OH
Product Type Devices
Quantity 34 units

Product Description

Ferno PROFlexx¿ Model 28Z Chair Cot

Reason for Recall

The recall was initiated as a result of the detection of an incorrect nut used in manufacturing.

Distribution Pattern

Worldwide distribution. The recalled products were distributed to the following states: CA, FL, HI, IL, NY, OH. There are no government accounts for this recall. There are no Canada accounts for this recall. There are no Mexico accounts for this recall. The recalled product was distributed to the following countries: Taiwan, United Arab Emirates, Thailand, Singapore

Lot / Code Information

17E003185, 17E003169, 17E003179, 17E003180, 17E003181, 17E003183, 17E003187, 17E003152, 17E003168, 17E003171, 17E003172, 17E003173, 17E003184, 17E003170, 17E003138, 17E003139, 17E003140, 17E003141, 17E003153, 17E003154, 17E003155, 17E003156, 17E003157, 17E003158, 17E003159, 17E003160, 17E003161, 17E003162, 17E003163, 17E003164, 17E003165, 17E003166, 17E003167, 17E003174

Other Recalls from Ferno-Washington Inc

Recall # Classification Product Date
Z-0133-2026 Class II FERNO POWER X2 POWERED AMBULANCE COT, Model/Cat... Sep 11, 2025
Z-0184-2023 Class II FERNO POWER X1 AMBULANCE COT- Item #0015807/UD... Oct 7, 2022
Z-1603-2016 Class II Poly-bags containing splint strap labeled with ... Mar 10, 2016
Z-1604-2016 Class II Poly-bags containing the strap labeled with "Ad... Mar 10, 2016
Z-2826-2015 Class II Ferno iNX Wheeled Stretcher, Integrated Patient... Aug 3, 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.