Recall Z-1779-2019 ยท FLE Sterilizer, Steam
Skytron, Div. The KMW Group, Inc
Skytron Integrity 270 Steam Sterilizer and Skytron Integrity 270VP Steam Product Usage: The SKYTRON Integrity 270 Steam Sterilizer for use in health care facilities. The Integrity Sterilizer incorporates high-pressure steam to sterilize nonporous or porous items and materials used in the health care industry
| Date | Apr 18, 2019 |
| Status | Terminated |
| Reason | Weld attaching the air heater assembly to the main sterilizer unit has shown signs of fatigue/failure |
| Root cause | Device Design |
| Action | Skytron issued Medical Device Correction letter on 4/18/19 via certified mail stating: reason for recall, action to be taken and will replace the air heater assembly on the affected devices. Contact Larry Perez, Vice President of Technical Services, at 616-656-2900 or www.lperez@skytron.us, or Bob Vreeland, at 616-656-1189 or www.bvreeland@skytron.us with any questions. For after-hours support, please call 1-800-759-8766 (SKYTRON). |
| Quantity | 5 units |
| Distribution | US Nationwide Distribution - AK, IA, MS |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132439 | SAKURA STEAM STERILIZER ASSR; -AO12, -A012W, -AO12P,-AO12PW / SKYTRON INTEGRITY 270;STEAM STERILIZER,VP STEAM STERILIZER Sakura Seiki Co., Ltd., Jan 6, 2014 |