Z-1129-2015Class II

Cold Therapy Pad - cold water circulating pad, one unit per package. The pads are used to provide a patient...

Name: Z-1129-2015 Cold Therapy Pad - cold water circulating pad, one unit per package. The pads are used to provide a patient...
Creator: Cincinnati Sub-Zero Products Inc
Published: 2015-01-07
License: https://open.fda.gov/license/

Gentherm Medical, LLC / initiated 2015-01-07 / Terminated / root cause: manufacturing process

FDA source

Cincinnati Sub-Zero Products Inc began a recall of 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... on 2015-01-07. FDA classified it as Class II and gives the reason as "Seals in the water path of the CT-99 cold therapy pad may separate during use, which could lead to a water leak". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1129-2015
Classification: Class II
Status: Terminated
Initiated: 2015-01-07
Posted: 2015-02-19
Terminated: 2015-06-19
Recalling firm: Gentherm Medical, LLC
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.
Product code: ILO Pack, Hot Or Cold, Water Circulating
Reason for recall: Seals in the water path of the CT-99 cold therapy pad may separate during use, which could lead to a water leak.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Cincinnati Sub-Zero sent an Urgent Medical Device Recall Field Action Notice dated January 7, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately cease use and/or further distribution of the affected product. Customers were instructed to obtain a Return Material Authorization Number and return the pad(s) for exchange. Customers with questions were instructed to call 1-800-989-7373 or 513-772-8810. Customers were also asked to commplete and return the enclosed Response Form as soon as possible by fax to (513)772-9119 to acknowledge receipt of the notification and to inform CSZ that they have performed the requested actions. For questions regarding this recall call 513-772-8810, ext 6816
Quantity in commerce: 1390
Distribution: Nationwide Distribution including FL, IL, TN, GA, VA, MO, NM, WI, MI, NC, IN, OH, MA, CA, WA, PA, KY, MD, HI, and AL.
Product codes and lots: Model: Catalog #CT -99 Part number: 50137 Lot number(s): 13380, 13390 and 13418.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1129-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1129-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-25	2015-02-19

Product code ILO

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)