Medical Device Recall: Z-0035-2010

FDA Recalls dataset · Firm: Cincinnati Sub-Zero Products Inc · Status: Terminated

Recall Action Class: N/A Date Initiated: 2009-02-16 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0035-2010.

Recall Res Number
Z-0035-2010
Recalling Firm / Manufacturer
Cincinnati Sub-Zero Products Inc
FEI Number
1516825
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2009-02-16
Date Posted
2009-10-29
Date Terminated
2012-09-19
Product Code
DWJ
Event Number
51228
Product Quantity
2,674 units
Product Description WarmAir 135 Thermal Regulating System. Catalog Numbers: 86186-115 V, 06186-115 V (sold in the U.S.) and #86185-100 V ( not sold in the U.S.). Intended for warming patients before, during and after surgery, and other specialty procedures.
Reason for Recall The blower on the WarmAir 135 Warming Unit may overheat. Resistance in a connector between circuit board and wiring harness results in excessive heat that may melt connector or deform the outer casing of the blower unit.
Action Details The firm sent an "URGENT Medical Device Recall' notice via First Class Mail on 2/16/2009 (Note: the letter is dated 2/13/2009). The notice informs the customers of the potential for the device to overheat and of the 'small number of customer complaints received by CSZ concerning this issue. In addition, the notice asks that the customers inspect their units for signs of discoloration indicative of a faulty connector. In the notice, the customers were instructed to return the product to CSZ for repair by contacting their Customer Service division and obtaining a Return Authorization number and specific instructions concerning packaging and returning of the unit(s) for repair. The customer is also instructed to complete the attached Recall Response Form which accompanies the recall notification. The notification provides that customer with a toll-free number at (800) 989-7373ext.3234 or call collect at (513) 719-3234 to reach CSZ representative between the hours of 8:30 a.m. until 4:30 P.M. Monday through Friday EST. Once the customer ships the recalled unit to CSZ, the firm will repair the unit(s) using new connectors manufactured, after which time, the repaired unit is returned to distribution for customer use.
Distribution Pattern Nationwide Distribution -- DE, TX, PA, NJ, LA, MI, GA, MA, OH, KY, NY, FL, NV, NC, MT, RI, WA, MN, AL, CT, MD, TN, UT, VA, CO, MO, IA, AZ, AR, IN, NE, KS, WI, ME, MS, and Puerto Rico.
Code Information / Serial Numbers Serial Numbers 994-1350001 to 083-1355822..

Related Establishments / Registrations

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