FDAFDA · Food and drugs·Recall number Z-0098-2018
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.
Published November 22, 2017 · Recall initiated: October 10, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Karl Storz Endoscopy
- Distributor
- Distribution was made nationwide. There was government distribution and no military distribution. Foreign distribution was made to Canada.
- Lot
- Lot #129241
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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