Class 2 Device Recall CT99 Cold Therapy Pad

• Date Initiated by Firm: January 07, 2015
• Date Posted: February 19, 2015
• Recall Status: Terminated on June 19, 2015
• Recall Number: Z-1129-2015
• Recall Event ID: 70207
• 510(K)Number: K902269 K843146
• Product Classification: Pack, hot or cold, water circulating - Product Code ILO
• 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.
• Code Information: Model: Catalog #CT -99 Part number: 50137 Lot number(s): 13380, 13390 and 13418.
• Recalling Firm/ Manufacturer: Cincinnati Sub-Zero Products Inc; 12011 Mosteller Rd; Cincinnati OH 45241-1528
• For Additional Information Contact: Kathy DeSmidt; 513-772-8810 Ext. 6816
• Manufacturer 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.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = ILO and Original Applicant = SEABROOK MEDICAL SYSTEMS, INC.