Medivators Endo carry-on Procedure Kit REF CPK-100222-0002 - Product Usage: is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures.
Check against the official notice below — it lists the full affected range.
Medivators, Inc. is recalling Endo SmartCap Tubing (Lot #1000028736, use-by date 210120) due to a manufacturing defect that may cause problems during medical procedures. The defect can result in inadequate insufflation, air bubbles inside the tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve. A total of 53,790 units were distributed worldwide, including throughout the United States, Australia, and England.
The recall notice does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve.
Reason for recall: Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve. Distribution: Worldwide distribution - US Nationwide distribution and the countries of Australia, England. Quantity: 53,790 units total Lot/code info: Lot # 1000028736 GTIN: 00677964086045 Use-by date: 210120
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.