Karl Storz Endoscopy recalls STORZ High Flow Insufflation Tubing (with filter), Catalog #20400161S/10 (outer box label), ENDOFLATOR 26-430520-1 also

Recalled November 22, 2017 · FDA recall Z-0098-2018 · Karl Storz Endoscopy

Hazard

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

Units

496/10-pouch boxes

Sold at

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

Description

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

Product

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.

Manufacturer(s)

Karl Storz Endoscopy

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →