FDA recall record

CareFusion 303 BD Pyxis" Anesthesia Station ES, REF: 327 recall — FDA Z-1931-2024

Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.

Class IIclassification
Z-1931-2024official record ID
Jun 5, 2024report date

Recall record at a glance

Official recordZ-1931-2024
CategoryMedical Device Recalls
ClassificationClass II
FDA record statusOngoing
Recalling firmCareFusion 303, Inc.
Report dateJun 5, 2024
Recall initiation dateApr 15, 2024
Quantity71,569 units
LocationSan Diego, CA, United States

Official product description

BD Pyxis" Anesthesia Station ES, REF: 327

Why the product was recalled

Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.

Distribution information

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MP, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of South Africa, Kuwait, Qatar, Singapore, Bermuda, United Arab Emirates, Argentina, Australia, Belgium, Bahrain, Brazil, Bahamas, Canada, Chile, China, Germany, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Ireland, Italy, Japan, South Korea, Lebanon, Morocco, Mexico, New Zealand, Oman, Portugal, Thailand, Taiwan.

How to read the classification

FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: not stated.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

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