Recall Z-2209-2013 ยท DWJ System, Thermal Regulating
Cincinnati Sub-Zero Products Inc
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.
| Date | Sep 16, 2013 (initiated Sep 3, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Labeling Change Control |
| Action | 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 |
| Quantity | 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 & WV. Internationally to ARGENTINA, AUSTRALIA, AZERBAIJAN, BELGIUM, CANADA, CHILE, CHINA, COSTA RIC |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101589 | BLANKETROL III, MODEL 233 AND COOLBLUE, MODEL 25-01 HYPER-HYPOTHERMIA SYSTEMS Cincinnati Sub-Zero Products, Inc., Sep 20, 2010 |