Model 134, WarmAir Convective Warming Device, 115V, Part #86180, Device Listing #D111865, The WarmAir 134 is used in con

FDA device recall Z-2800-2011 · posted 2011-07-14 · Terminated

Recall details

Recalling firm

Cincinnati Sub-Zero Products Inc

Reason for recall

A component defect. The recalling firm determined that one of the connectors attached to the firm's WarmAir 134 device's Printed Circuit Board (PCB) can overheat. Should this event occur, the excess heat build up within the device may result in damage to the device's external case and/or melting of some of the internal components of the unit.

Action taken

CSZ Cincinnati Sub-Zero sent an "URGENT MEDICAL DEVICE RECALL FIELD ACTION" notice to all affected customers. The letter identifies the product, problem, and actions to be taken. CSZ instructs customers to complete and return an enclosed recall response form and to state whether or not their facility is in possession of the device. The completed form should be returned via fax at 513-772-9119 or via e-mail to WA134Recall2011@cszinc.com. Additionally, customers are instructed to discontinue use of the device and return to their Biomedical Engineering and/or Service Department for device exchange and return. Questions regarding this notice are directed to the WarmAir 134 field action (recall) administrator at 1-800-989-7373.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

DWJ

Quantity affected

463 units were distributed

Distribution

Worldwide Distribution--USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, LA, MA, MI, MO, NC, NJ, NM, NV, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI

Date initiated

2011-05-19

Date posted

2011-07-14

Date terminated

2013-02-26

Location

Cincinnati, OH