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Terminated

C1140 Flexible Endoscope Processing Container and Tray assembly.

FDA Recall Z-0830-03 · Posted 2003-05-15

Recalling FirmSteris Corp
Recall StatusTerminated
Product CodeMLR
Date Initiated2003-04-23
Date Terminated2004-02-05
Product Quantity354 units

Reason for Recall

The container flow port is inverted, which restricts the flow of sterilant to the endoscope and affects the sterilization process.

Firm Action

The firm notified their customers by telephone and letter on 4/23/2003.

Root Cause

Other

Distribution Pattern

The product was shipped to end-users located nationwide and worldwide.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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