Recall Z-0508-2019 ยท HIF Insufflator, Laparoscopic
WOM World of Medicine AG
PNEUMOCLEAR Heated High-Flow Tube Set Product Usage: The Heated High-Flow Tube Set is a single use sterile tube set used in combination with the PNEUMOCLEAR C02 insufflator as a separate accessory. The device PNEUMOCLEAR is a C02 insufflator intended for use during diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. The Standard, High Flow/Bariatric,
| Date | Oct 22, 2018 |
| Status | Terminated |
| Reason | It is possible that the packaging of the product can be damaged by the prongs on the tube set. |
| Root cause | Packaging process control |
| Action | WOM sent a Recall Notification letter dated October 22, 2018 to the their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to send all in the US recalled products back to: W.O.M. WORLD OF MEDICINE USA, Inc. 4531 36th Street Orlando, FL 32811-6527 WOM contacts for coordinating the shipment of the requested products to Orlando: Customer Service -W.O.M. Orlando Phone: +1 407 472 0372 Customer Service -W.O.M. Orlando Phone: +1 407 472 0371 Please send all recalled products returned to Stryker Venlo/Netherlands back to: W.O.M. W |
| Quantity | 124,180 tube sets |
| Distribution | Worldwide Distribution - US in the state of California and country of Netherlands |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170784 | PNEUMOCLEAR W.O.M. World of Medicine GmbH, May 15, 2017 |