Recall Z-0098-2018 ยท NKC Tubing/Tubing With Filter, Insufflation, Laparoscopic
Karl Storz Endoscopy
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 THER
| Date | Oct 10, 2017 |
| Status | Terminated |
| 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. |
| Root cause | Labeling mix-ups |
| Action | The recalling firm issued letters flagged as 'SAFETY ALERT" dated 10/5/2017 via Federal Express on 10/10/2017. |
| Quantity | 496/10-pouch boxes |
| Distribution | Distribution was made nationwide. There was government distribution and no military distribution. Foreign distribution was made to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.