FDA recall Z-0098-2018

Karl Storz Endoscopy · Class II · 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.

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

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

Key facts

Status
Terminated
Initiation date
2017-10-10
Report date
2017-11-22
Termination date
2018-06-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
El Segundo, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0098-2018