115 V Blanketrol II, Model 222S Hyper-Hypothermia System . Used to lower or to raise a patients temperature and /or main

FDA device recall Z-1679-2014 · posted 2014-06-10 · Terminated

Recall details

Recalling firm

Cincinnati Sub-Zero Products Inc

Reason for recall

The incorrect voltage component was placed into the device during manufacturing. This may make the device unable to maintain patient temperature during cooling mode. The device will continue to indicate that the unit is cooling because the compressor will continue to run, however water in the reservoir will begin to return to ambient temperature. The actual water temperature will be displayed but

Action taken

The firm initiated a telephone notification on 01/08/2014, followed by a written notification which was sent to the customers via letter or email on 01/31/2014. URGENT Medical Device Field Action (January 31, 2014) REF: 115V Blanketrol II Model 22S Hyper-Hypothermia System (1) Discontinue Use and contact CSZ (2)Upon receipt of new 115V (p/n 91113) solenoid coil(s), immediately remove and destroy/discard all the affected 220V (p/n 3600) solenoid coil(s) (3)After the affected 220V (p/n 36007) solenoid coil(s) have been removed, discard and replaced, please complete and return the enclosed response form as soon as possible to acknowledge receipt of this notification and to imform CSZ that you have performed and completed the requested actions. Return the form by fax

Root cause

Mixed-up of materials/components

Status

Terminated

Product code

DWJ

Quantity affected

7 units

Distribution

The product was distributed to one customer in MI, and internationally (Taiwan)

Date initiated

2014-01-08

Date posted

2014-06-10

Date terminated

2014-06-06

Location

Cincinnati, OH

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