Z-0098-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 22, 2017
- Initiation Date
- October 10, 2017
- Termination Date
- June 22, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 496/10-pouch boxes
Product Description
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.
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.
Distribution Pattern
Distribution was made nationwide. There was government distribution and no military distribution. Foreign distribution was made to Canada.
Code Information
Lot #129241