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Terminated

STORZ High Flow Insufflation Tubing (with filter), Catalog #20400161S/10 (outer box label), ENDOFLATOR 26-430520-1 also referenced on outer box), individually packaged in a sterile pouch (Catalog #20400161S), 10 pouches per cardboard box. Some of the pouches inside of cardboard box are incorrectly labeled as Catalog number 20400162S, High Flow Insufflation Tubing (with filter) For 26432020-1 THERMOFLATOR. The firm name on the label is Karl Storz Endoscopy-America, Inc., El Segundo, CA.

FDA Recall Z-0098-2018 · Posted None

Recalling FirmKarl Storz Endoscopy
Recall StatusTerminated
Product CodeNKC
Date Initiated2017-10-10
Date Terminated2018-06-22
Product Quantity496/10-pouch boxes

Reason for Recall

The label outside the cardboard box is labeled correctly but the pouches inside of some of the boxes were mislabeled as a different product.

Firm Action

The recalling firm issued letters flagged as 'SAFETY ALERT" dated 10/5/2017 via Federal Express on 10/10/2017.

Root Cause

Labeling mix-ups

Distribution Pattern

Distribution was made nationwide. There was government distribution and no military distribution. Foreign distribution was made to Canada.

Official Source

View FDA Recall →

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

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