Recall Z-3119-2011 ยท DWJ System, Thermal Regulating
Cincinnati Sub-Zero Products Inc
Operations and Technical Manuals for the firm's WarmAir Model 135 Hyperthermia System (115V, 100V, and 230/240V), 510 (k) #K101148, Serial Numbers: 994-1350001 through 104-1356894. The WarmAir 135 Hyperthermia System is a patient temperature management device which provides forced air warmed by the controller to ... a blanket that is placed over or around adult, pediatric or neonatal patients
| Date | Sep 1, 2011 (initiated Jul 20, 2011) |
| Status | Terminated |
| Reason | Cincinnati Sub-Zero is conducting a field correction due to changes that have been made to the WarmAir Model 135 devices Operation and Technical Manuals in order to comply with FDA device labeling regulations. |
| Root cause | Labeling design |
| Action | Cincinnati Sub-Zero Products, Inc. sent an 'URGENT Medical Device Recall Field Action Notice" dated July 27, 2011, to all affected user/customers. The letter includes: description of device; the problem with the suspect manuals, and provides contact information for the customers to use to request new versions of the manuals. Upon receipt of the new manuals, the customers are asked to immediately collect and destroy/discard all of the old manuals at their facility and to replace them with the new versions. After the manuals have been discarded and replaced, the customers are asked to complete |
| Quantity | 6561 units were distributed. |
| Distribution | Nationwide distribution: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NJ, NM, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101148 | WARM AIR MODEL 135 HYPERTHERMIA SYSTEM AND BLANKETS Cincinnati Sub-Zero Products, Inc., Oct 1, 2010 |