Poly-bags containing the strap labeled with "Adult" sticker. Each strap kit contains adjustabl...
FDA Device Recall #Z-1604-2016 — Class II — March 10, 2016
Recall Summary
| Recall Number | Z-1604-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 10, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Ferno-Washington Inc |
| Location | Wilmington, OH |
| Product Type | Devices |
| Quantity | 270 |
Product Description
Poly-bags containing the strap labeled with "Adult" sticker. Each strap kit contains adjustable length leg straps, ankle wrap, a thigh pad and a heel stand. The strap kits are applied to the traction splint frame to immobilize and provide traction for a patients leg.
Reason for Recall
On March 9, 2016, the firm was contacted regarding the possibility of incorrect labeling on the outside poly- bag of the traction splint straps. The firm investigated and determined its supplier had labeled the outside packaging for the pediatric and adult traction splints straps incorrectly. The packaging labeled Adult contained a pediatric splint strap and the packaging labeled Pediatric conta
Distribution Pattern
Worldwide Distribution - US Distribution to the states of : AK ,AZ ,CA, CO, FL ,GA ,HI, IL ,IN ,KY ,MA ,MI ,MS ,NC ,NE ,NJ ,NY ,OH,ON,TX ,VA ,WI , and WV. There are no government accounts for this recall. There is one Canadian account for this recall. There are no Mexican accounts for this recall. and to the countries of : UAE, MALAYSIA, UNITED KINGDOM, SLOVAKIA, SOUTH AFRICA, QATAR and AUSTRALIA..
Lot / Code Information
Strap Kit Adult Model 444
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-1827-2017 | Class II | Ferno PROFlexx¿ Model 28Z Chair Cot | Mar 8, 2017 |
| Z-1603-2016 | Class II | Poly-bags containing splint strap labeled with ... | 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.