Blanketrol III, Model Number 233, Cincinnati Sub-Zero Products, Inc., 12011 Mosteller Road, Cincinnati, OH 45241 Hyper-H

FDA device recall Z-2209-2013 · posted 2013-09-16 · Terminated

Recall details

Recalling firm

Cincinnati Sub-Zero Products Inc

Reason for recall

During a label review it was discovered that both the Blanketrol III Operations (57201-N) & Operations & Technical (56201-Q) manuals had verbiage added back into the manual during ECN M111-4260 (released 12/29/2011) which was previously removed for clarification of the intended use and subsequent 501(K) approval.

Action taken

Cincinnati Sub-Zero (CSZ) sent an Urgent Medical Device Field Action letter dated September 5, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contact CSZ at 513-772-8810 or 1-800-989-7373 to request new versions of the manuals. At that time customers are instructed to provide the quantity and serial numbers of the affected devices that are at their facility. Upon receipt of the new versions of the manual, immediately collect and destroy/discard all the affectred devices Operation and Technical Manuals their facility is currentlyin possession of and replace the discarded manuals with the new versions of the manuals provided by CSZ. After the manuals have been discarded and replaced, customers were asked to complete and return the enclosed response form as soon as possible to acknowledge receipt of this notification and to inform CSZ that they have performed and completed the requested actions. Customers should return the form by fax to 513-772-9119 scan and email the information to B3manual@cszinc.com or mail to Cincinnati Sub-Zero, 12011 Mosteller Road, Cincinnati, Ohio 45241. Customers with questions were instructed to contact their Blanketrol III Model 233 field action coordinator at 1-800-989-7373 or 513-772-8810. For questions regarding this recall call 513-772-8810, ext 5295.

Root cause

Labeling Change Control

Status

Terminated

Product code

DWJ

Quantity affected

115V - 396 units; 230V - 385 units

Distribution

Worldwide Distribution - USA including AK, AR, AZ, CA, CO, DC, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MT, , NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, WA, WI

Date initiated

2013-09-03

Date posted

2013-09-16

Date terminated

2014-08-22

Location

Cincinnati, OH

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