C1140 Flexible Endoscope Processing Container and Tray assembly.
FDA device recall Z-0830-03 · posted 2003-05-15 · Terminated
Recall details
- Recalling firm
- Steris Corp
- Reason for recall
- The container flow port is inverted, which restricts the flow of sterilant to the endoscope and affects the sterilization process.
- Action taken
- The firm notified their customers by telephone and letter on 4/23/2003.
- Root cause
- Other
- Status
- Terminated
- Product code
- MLR
- Quantity affected
- 354 units
- Distribution
- The product was shipped to end-users located nationwide and worldwide.
- Date initiated
- 2003-04-23
- Date posted
- 2003-05-15
- Date terminated
- 2004-02-05
- Location
- Mentor, OH
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