Blanketrol III, Model Number 233, Cincinnati Sub-Zero Products, Inc., 12011 Mosteller Road, Cincinnati, OH 45241 Hyper-Hypothermia device used to lower or to raise a patients temperature and/or maintain a desired patient temperature through conductive heat transfer.
Recall
- Recall Number
- Z-2209-2013
- Event Number
- 66155
- Firm
- Cincinnati Sub-Zero Products Inc
- FEI Number
- 1516825
- Product Code
- DWJ
- Status
- Terminated
- Root Cause
- Labeling Change Control
- Initiated
- September 3, 2013
- Posted
- September 16, 2013
- Terminated
- August 22, 2014
- Address
- 12011 Mosteller Rd, Cincinnati, OH, 45241-1528
Description
Blanketrol III, Model Number 233, Cincinnati Sub-Zero Products, Inc., 12011 Mosteller Road, Cincinnati, OH 45241 Hyper-Hypothermia device used to lower or to raise a patients temperature and/or maintain a desired patient temperature through conductive heat transfer.
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.
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 [email protected] 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.
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 & WV. Internationally to ARGENTINA, AUSTRALIA, AZERBAIJAN, BELGIUM, CANADA, CHILE, CHINA, COSTA RICA, CROATIA, GERMANY, HONDURAS, HONG KONG, INDIA, INDONESIA, ISRAEL, KOREA, KUWAIT, MEXICO, NEW ZEALAND, PERU, SAUDI ARABIA, SINGAPORE, SPAIN, TAHITI, THAILAND, THE NETHERLANDS, THE PHILIPPINES, UNITED ARAB EMERITES & UNITED KINGDOM.
115V - 396 units; 230V - 385 units