The Recall Desk
ModerateFDA (Devices)·Z-1129-2015·Announced 2015-02-25

Cincinnati Sub-Zero CT-99 Cold Therapy Pad Recall for Seal Separation

Cincinnati Sub-Zero is recalling CT-99 cold therapy pads because seals may separate during use, causing water leaks.

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: The recall is classified as FDA Class II. The hazard is a water leak due to seal separation, which is a functional defect without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Cincinnati Sub-Zero Products Inc is recalling 1,390 units of the CT-99 Cold Therapy Pad. These pads are used to provide local cold therapy by circulating chilled water through a pad positioned on a patient. The recall involves specific catalog and part numbers, as well as lot numbers 13380, 13390, and 13418.

The recall is being issued because seals in the water path of the device may separate during use. This defect could lead to a water leak. The affected units were distributed nationwide, including in Florida, Illinois, Tennessee, Georgia, Virginia, Missouri, New Mexico, Wisconsin, Michigan, North Carolina, Indiana, Ohio, Massachusetts, California, Washington, Pennsylvania, Kentucky, Maryland, Hawaii, and Alabama.

Consumers should stop using the affected cold therapy pads immediately. The source text does not specify a particular consumer action beyond the recall notice, but standard procedure for medical device recalls involves contacting the manufacturer or healthcare provider for instructions on replacement or refund.

The recalled product

Product
Cold Therapy Pad - cold water circulating pad, one unit per package. The pads are used to provide a patient with local cold therapy by circulating chilled water through the pad that has been positioned on the patient.
Affected units
1,390

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 #CT -99 Part number: 50137 Lot number(s): 13380
  • 13390 and 13418.

Distribution

Distributed nationwide across the United States.

The notice also names 20 states specifically: