DonJoy IceMan CLASSIC3 Cold Therapy Unit Connector Defect
DJO, LLC is recalling the DONJOY IceMan CLASSIC3 cold therapy unit (Model 11-1422) due to a broken connector that may interrupt prescribed cold therapy treatment.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall for a medical device with a connector defect that may result in temporary interruption of therapy. No injuries or hospitalizations are reported in the source text, and the hazard is a temporary service interruption rather than direct patient harm, making this a moderate-severity precautionary recall.
Plain-English summary
The DONJOY IceMan CLASSIC3 cold therapy unit (Model 11-1422) is being recalled because the device may have a broken connector that could cause a temporary interruption of prescribed cold therapy. The IceMan CLASSIC3 is designed to reduce pain and swelling and aid in rehabilitation as directed by medical professionals using DonJoy's recirculation technology.
Approximately 1,412 units have been distributed worldwide and throughout U.S. states including Alaska, Alabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, Nebraska, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, and West Virginia, as well as Canada. Affected lot codes are 101325 and 101425.
Consumers who have purchased this device should stop using it if they experience any interruption in cold therapy and contact their healthcare provider or DJO, LLC for further assistance.
The recalled product
- Product
- Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,RH Model/Catalog Number: 11-1422 Software Version: no Product Description: 11-1422 - ICEMAN W/,UNIV,LOOP,NS,RH The IceMan CLASSIC3¿ cold therapy unit helps reduce pain and swelling, speeding up rehabilitation. The IceMa
- Manufacturer
- DJO, LLC
- Hazard
- connector-defect
- therapy-interruption
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Model/Catalog Number: 11-1422 Lot Code: Lot: 101325
- 101425 GTIN: 00888912005869
Distribution
Distributed nationwide across the United States.