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

FDA device recall Z-1129-2015 · posted 2015-02-19 · Terminated

Recall details

Recalling firm

Cincinnati Sub-Zero Products Inc

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.

Action taken

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

Root cause

Process design

Status

Terminated

Product code

ILO

Quantity affected

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.

Date initiated

2015-01-07

Date posted

2015-02-19

Date terminated

2015-06-19

Location

Cincinnati, OH

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