FDA-Device2025-11-05Class IIPACKAGING DEFECT
Various models of BD Pyxis MedFlex, Reference numbers: 1119-00 1139-00 139038-01 139039-01 139040-01 139041-01 139043-01 139044-01 139045-01 139046-01 139049-01 139051-01 139052-01 139053-01 139054-01 139055-01 139056-01 139058-01 139059-01 139060-01 139061-01 139064-01 139065-01 139066-01 139067-01 139068-01 139069-01 139070-01 139071-01 139072-01 139164-01 139165-01 300
Hazard
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide distribution - US Nationwide and the countries of Canada, United Arab Emirates, Australia.
Affected count
2,755 units
Manufactured in
10020 Pacific Mesa Blvd, N/A, San Diego, CA, United States
Products
Various models of BD Pyxis MedFlex, Reference numbers: 1119-00 1139-00 139038-01 139039-01 139040-01 139041-01 139043-01 139044-01 139045-01 139046-01 139049-01 139051-01 139052-01 139053-01 139054-01 139055-01 139056-01 139058-01 139059-01 139060-01 139061-01 139064-01 139065-01 139066-01 139067-01 139068-01 139069-01 139070-01 139071-01 139072-01 139164-01 139165-01 300
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0368-2026Want us to check the next one for you?
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