Operations and Technical Manuals for the firm's WarmAir Model 135 Hyperthermia System (115V, 100V, and 230/240V), 510 (k

FDA device recall Z-3119-2011 · posted 2011-09-01 · Terminated

Recall details

Recalling firm

Cincinnati Sub-Zero Products Inc

Reason for recall

Cincinnati Sub-Zero is conducting a field correction due to changes that have been made to the WarmAir Model 135 devices Operation and Technical Manuals in order to comply with FDA device labeling regulations.

Action taken

Cincinnati Sub-Zero Products, Inc. sent an 'URGENT Medical Device Recall Field Action Notice" dated July 27, 2011, to all affected user/customers. The letter includes: description of device; the problem with the suspect manuals, and provides contact information for the customers to use to request new versions of the manuals. Upon receipt of the new manuals, the customers are asked to immediately collect and destroy/discard all of the old manuals at their facility and to replace them with the new versions. After the manuals have been discarded and replaced, the customers are asked to complete and return the attached "Recall Response Form" via fax to (513) 772-9119 or scan and email to WA135manual@cszinc.com or mail to Cincinnati Sub-Zero, 12011 Mosteller Road, Cincinnati, OH 45241. For additional information the customers are provided with an e-mail address: WA135-2011@cszinc.com as well as a toll-free telephone number and fax number to reach the firm and obtain additional information as necessary. The contact numbers are: 1 (800) 989-7373, or (513) 772-8810, and/or fax # (513) 772-9119..

Root cause

Labeling design

Status

Terminated

Product code

DWJ

Quantity affected

6561 units were distributed.

Distribution

Nationwide distribution: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NJ, NM, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, and WI.

Date initiated

2011-07-20

Date posted

2011-09-01

Date terminated

2013-07-05

Location

Cincinnati, OH

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