ClearanceBrief
Recall Z-0830-03 ยท MLR Sterilizer, Chemical

Steris Corp

C1140 Flexible Endoscope Processing Container and Tray assembly.

DateMay 15, 2003 (initiated Apr 23, 2003)
StatusTerminated
ReasonThe container flow port is inverted, which restricts the flow of sterilant to the endoscope and affects the sterilization process.
Root causeOther
ActionThe firm notified their customers by telephone and letter on 4/23/2003.
Quantity354 units
DistributionThe product was shipped to end-users located nationwide and worldwide.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.