Medivators EndoGator REF 100651. Kit for Olympus 140/160/180/190 Series GI Endoscopes for CO2 Connection with Endogator EGP-100, Olympus OFP, Olympus AFU-100 & Erbe EIP 2 Irrigation Pump Units. Contents 10. Sterile EO. of 100145CO2EXT Endo SmartCap Irrigation Tubing for Olympus 140/160/180/190 Series GI Endoscopes with Extended CO2 Input - 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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot # / Case UDI#s: 430358 / 2067796406530322060110430358, 429884 / 2067796406530322060110429884, 428806 / 2067796406530322070110428806, 430568 / 2067796406530322060110430568, 431254 / 2067796406530322070110431254, 431455 / 2067796406530322070110431455, 431603 / 2067796406530322070110431603, 431834 / 2067796406530322070110431834, 431985 / 2067796406530322070110431985, 431973 / 2067796406530322070110431973, 432922 / 2067796406530322070110432922, 432108 / 2067796406530322070110432108, 432921 / 2067796406530322070110432921, 433116 / 2067796406530322070110433116, 433115 / 2067796406530322080110433115.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Medivators, Inc.
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Medivators EndoGator REF 100651. Kit for Olympus 140/160/180/190 Series GI Endoscopes for CO2 Connection with Endogator EGP-100, Olympus OFP, Olympus AFU-100 & Erbe EIP 2 Irrigation Pump Units. Contents 10. Sterile EO. of 100145CO2EXT Endo SmartCap Irrigation Tubing for Olympus 140/160/180/190 Series GI Endoscopes with Extended CO2 Input - 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.
Product Codes/Lot Numbers:
Lot # / Case UDI#s: 430358 / 2067796406530322060110430358, 429884 / 2067796406530322060110429884, 428806 / 2067796406530322070110428806, 430568 / 2067796406530322060110430568, 431254 / 2067796406530322070110431254, 431455 / 2067796406530322070110431455, 431603 / 2067796406530322070110431603, 431834 / 2067796406530322070110431834, 431985 / 2067796406530322070110431985, 431973 / 2067796406530322070110431973, 432922 / 2067796406530322070110432922, 432108 / 2067796406530322070110432108, 432921 / 2067796406530322070110432921, 433116 / 2067796406530322070110433116, 433115 / 2067796406530322080110433115.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1777-2020
Related Recalls
The lot may have experienced an anomaly during the manufacturing process, that could lead to an out of specification concentrate formulation.
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.
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.