STORZ High Flow Insufflation Tubing recalled over labeling errors

Recall date

October 10, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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

Recall number

Z-0098-2018

FDA classification

Class II

Brand / firm

Karl Storz Endoscopy

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.