Recall Z-0098-2018— Karl Storz Endoscopy
Class II · Terminated
Class II FDA medical device recall by Karl Storz Endoscopy, initiated 2017-10-10, terminated 2018-06-22. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Karl Storz Endoscopy
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-10-10
- Terminated
- 2018-06-22
- Firm location
- El Segundo, CA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.