OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector
Reported: October 26, 2016 Initiated: June 23, 2016 #Z-0138-2017
Product Description
OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector
Reason for Recall
New warning requiring Users to conduct duodenoscope precleaning and manual cleaning even when using an Automated Endoscope Reprocessor (AER) that has instructions that may indicate a user could forego certain steps in precleaning and manual cleaning of the endoscopes.
Details
- Recalling Firm
- Olympus Corporation of the Americas
- Units Affected
- 2, 686 units
- Distribution
- Distributed to: AK,AL,AR,AZ,CA,CO,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,MT,NC,ND,NE,NH,NJ,NM,NV,NY,OH,OK,OR,PA,RI,SC,TN,TX,UT,VA,VT,WA,WI,WV,WY
- Location
- Center Valley, PA
Frequently Asked Questions
What product was recalled? ▼
OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector. Recalled by Olympus Corporation of the Americas. Units affected: 2, 686 units.
Why was this product recalled? ▼
New warning requiring Users to conduct duodenoscope precleaning and manual cleaning even when using an Automated Endoscope Reprocessor (AER) that has instructions that may indicate a user could forego certain steps in precleaning and manual cleaning of the endoscopes.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 26, 2016. Severity: Moderate. Recall number: Z-0138-2017.
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