Recall Z-1942-2020 ยท NKC Tubing/Tubing With Filter, Insufflation, Laparoscopic
Karl Storz Endoscopy
Insufflation tubing to be used with varies insufflator units. REF 031200-10; REF 031322-10; REF 031532-10; REF 031622-10
| Date | Jan 9, 2019 |
| Status | Terminated |
| Reason | The sterile single-use tubing may contain higher ethylene oxide (EO) residues than the acceptable level. |
| Root cause | Vendor change control |
| Action | The recalling firm sent an URGENT SAFETY NOTICE OF PRODUCT RECALL (via FedEx) to the impacted customers on 01/09/20120, along with acknowledgement confirmation for customer to sign and return it to the firm. |
| Quantity | 543 boxes were distributed; 10 ea per box. |
| Distribution | 57 consignees in the US. AL,AZ,CA,CT,DE,FL,GA,IL,LA,MA,MD,ME,MI,MN,NE,NH,NJ,NY,OH,OK,PA,SC,TX,VA,VT,WA and WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.