Recall Z-1773-2020
Medivators, Inc. · initiated October 9, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Medivators Endo Smartcap Endoscope Tubing. REF100145CO2, packaged as Contents 1, 10, 50 and found in BMP-C145CO2. Tubing for Olympus 140/240, 160/260, 180/280, 190/290 Series Endoscopes. Sterile EO - 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.
Codes / lots: Lot # / UDI #s: 426399 / 006779640594692207241426399, 426401 / 006779640594692207241426401.
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.
FDA-determined cause: Equipment maintenance
Action taken
An Urgent Medical Device Recall Notification letter was sent to customers via certified mail next day delivery on 10/09/2019. The letter identified affected product, stated reason for recall, asked for product to be quarantined and discontinue use. Customers are to return product to Medivators by obtaining a Return Material Authorization from Customer Service. A response form was asked to be returned. Questions can be directed to Customer Service at 1-800-444-4729.
Details
- Recall number
- Z-1773-2020
- Initiated
- October 9, 2019
- Terminated
- December 11, 2020
- Product code
- FAJ – Cystoscope And Accessories, Flexible/Rigid
- Quantity
- 53,790 units total
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Australia, England.
- Recalling firm
- Medivators, Inc., Plymouth, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1772-2020 Class II | Medivators Endo Smartcap Endoscope Tubing. REF100145. Packaged as Contents 1, 10, 50…Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during… | 10/09/2019Terminated |
| Z-1774-2020 Class II | Medivators Endo Smartcap Endoscope Tubing. REF100145CO2EXTU, packaged as Contents 1, 10…Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during… | 10/09/2019Terminated |
| Z-1775-2020 Class II | Medivators Endo Smartcap Endoscope Tubing. REF100145CO2EXT, packaged as Contents 1, 10…Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during… | 10/09/2019Terminated |
| Z-1776-2020 Class II | Medivators EndoGator REF 100650. Kit for Olympus 140/160/180/190 Series GI Endoscopes…Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during… | 10/09/2019Terminated |
| Z-1777-2020 Class II | Medivators EndoGator REF 100651. Kit for Olympus 140/160/180/190 Series GI Endoscopes…Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during… | 10/09/2019Terminated |
| Z-1778-2020 Class II | Medivators Endo carry-on Procedure Kit REF CPK-100222-0002 - Product Usage: is intended…Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during… | 10/09/2019Terminated |