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Medivators EndoGator REF 100650. Kit for Olympus… recallZ-1776-2020 · Medivators, Inc. · initiated Oct 9, 2019

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medivators, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Equipment maintenance

What the company is doing

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.

Recall details

Recall number
Z-1776-2020
Status
Terminated
Initiated by the company
Oct 9, 2019
Recalling firm
Medivators, Inc.
Quantity
53,790 units total
Product code
FAJ
FDA submissions
K093665
Distribution
Worldwide distribution - US Nationwide distribution and the countries of Australia, England.

Product description

Medivators EndoGator REF 100650. Kit for Olympus 140/160/180/190 Series GI Endoscopes forCO2 Connection with Olympus OFP or Boston Scientific Endostat II Irrigation Pump Units. Contents 10. Sterile EO. of 100145CO2EXT Endo SmartCap Irrigation Tubing for Olympus 140/240, 160/260, 180/280, 190/290 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.

Code information (models, lots, serial numbers)

Lot # / Case UDI#s: 429694 / 2067796406529722070110429694,  429695 / 2067796406529722060110429695,  430357 / 2067796406529722070110430357,  430566 / 2067796406529722070110430566,  432106 / 2067796406529722080110432106,  431602 / 2067796406529722070110431602,  431611 / 2067796400000722070110431611,  431972 / 2067796406529722070110431972,  432728 / 2067796406529722080110432728,  431833 / 2067796406529722080110431833,  432920 / 2067796406529722080110432920,  432919 / 2067796406529722080110432919.

Other devices under the same FDA submission

5 devices cleared under K093665 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 84109).

Sources and updates

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