115V Blanketrol III Model 233 Hyper/Hypothermia System, Part number: 86107; and 115V CoolBlue Model 25-01 Hyper/Hypother

FDA device recall Z-1817-2011 · posted 2011-03-30 · Terminated

Recall details

Recalling firm

Cincinnati Sub-Zero Products Inc

Reason for recall

The firm initiated this recall due to changes that have been made to the Blanketrol III Model 233 device's Operation and Operation/Technical Service Manuals, in order to stay in compliance with labeling regulations.

Action taken

On 10/18/2010 & 11/5/2010 the firm sent URGENT Medial Device Field Action letters, dated 10/18/2010, to their customers. The letters identified the affected product and stated the reason for recall. Customers were instructed to immediately collect and discard all affected product Operation and Operation/Technical Service manuals currently in their possession. They were to replace all the discarded manuals with the revised versions that were provided with the letter. The enclosed response form should be completed and returned by fax to 513-772-9119, scanned and e-mailed to B3manual@cszinc.com. If the product had been further distributed, then those customers should also be identified and notified of the field action via a copy of the letter. Customers should direct questions to the field action coordinator, David Niehaus at 513-773-8810 ext. 3234.

Root cause

Other

Status

Terminated

Product code

DWJ

Quantity affected

763 - 115V Blanketrol III Model 233; & 133 - 115V CoolBlue Model 25-01

Distribution

Worldwide Distribution -- US, including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI

Date initiated

2010-10-18

Date posted

2011-03-30

Date terminated

2013-03-08

Location

Cincinnati, OH

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