Olympus JF-140F duodenoscopes (Model NumberJF-140F)
Reported: June 27, 2018 Initiated: May 11, 2018 #Z-2269-2018
Product Description
Olympus JF-140F duodenoscopes (Model NumberJF-140F)
Reason for Recall
Issuance of validated, new reprocessing procedures. This corrective action is being undertaken as a result of ongoing manufacturer and FDA activities relating to reported patient infections associated with duodenoscopes. The new cleaning procedure requires additional recess flushing and forceps elevator raising/lowering steps during precleaning, manual cleaning and manual disinfection.
Details
- Recalling Firm
- Olympus Corporation of the Americas
- Units Affected
- 994
- Distribution
- Nationwide
- Location
- Center Valley, PA
Frequently Asked Questions
What product was recalled? ▼
Olympus JF-140F duodenoscopes (Model NumberJF-140F). Recalled by Olympus Corporation of the Americas. Units affected: 994.
Why was this product recalled? ▼
Issuance of validated, new reprocessing procedures. This corrective action is being undertaken as a result of ongoing manufacturer and FDA activities relating to reported patient infections associated with duodenoscopes. The new cleaning procedure requires additional recess flushing and forceps elevator raising/lowering steps during precleaning, manual cleaning and manual disinfection.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 27, 2018. Severity: Moderate. Recall number: Z-2269-2018.
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