Z-1778-2020 Class II Terminated
FDA device recall Z-1778-2020 was initiated by Medivators, Inc. on October 9, 2019 and is designated Class II. 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, insu… The recall status is terminated (terminated December 11, 2020). Affected quantity: 53,790 units total.
Recall Details
- Product Type
- Devices
- Report Date
- April 29, 2020
- Initiation Date
- October 9, 2019
- Termination Date
- December 11, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 53,790 units total
Product Description
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.
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 Pattern
Worldwide distribution - US Nationwide distribution and the countries of Australia, England.
Code Information
Lot # 1000028736 GTIN: 00677964086045 Use-by date: 210120