Device 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.
Z-0098-2018
Product summary
- Event
- Event 78289
- Status
- Terminated
- Classification
- Class II
- Quantity
- 496/10-pouch boxes
- Official record key
device-enforcement:Z-0098-2018
Official wording
Reason: The label outside the cardboard box is labeled correctly but the pouches inside of some of the boxes were mislabeled as a different product.
Code information: Lot #129241
Distribution pattern: Distribution was made nationwide. There was government distribution and no military distribution. Foreign distribution was made to Canada.
Derived failure modes
-
Labeling or packaging
mislabeled