DJO, LLC — Class II: Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,EH Model/Catalog Number: 11-1424
DJO, LLC has initiated a Class II recall for the DonJoy IceMan CLASSIC3 cold therapy unit due to a broken connector. This defect may cause a temporary interruption in prescribed cold therapy treatment.
DJO, LLC, healthcare providers utilizing cold therapy systems, and quality/regulatory personnel managing orthopedic rehabilitation devices.
A broken connector suggests a potential mechanical vulnerability in the device's recirculation system. For regulatory teams, this highlights the importance of monitoring component durability, as failure to maintain treatment continuity—even if temporary—can trigger formal recall actions to address safety or performance inconsistencies.
QA and engineering teams should evaluate the mechanical integrity of device connectors to ensure they meet durability requirements. Regulatory and complaint handling departments should monitor for similar failure modes in cold therapy recirculation systems to prevent interruptions in prescribed treatment.
Class II. Reason: Due to broken connector which may result in a temporary interruption of prescribed cold therapy.. Product: Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,EH Model/Catalog Number: 11-1424 Software Version: No Product Description: 11-1424 - ICEMAN W/,UNIV,LOOP,NS,EH The IceMan CLASSIC3¿ cold therapy unit helps reduce pain and swelling, speeding up rehabilitation. The IceMan¿ helps provide extended cold therapy to aid in a variety of indications and protocols as directed by a medical professional. The IceMan CLASSIC3 utilizes DonJoy's recirculation technology. Component: No. Firm: DJO, LLC (Carlsbad CA United States). Status: Ongoing.
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