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U.S. Department of Health and Human Services

Class 2 Device Recall BD Pyxis(TM) Anesthesia Station 4000

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 Class 2 Device Recall BD Pyxis(TM) Anesthesia Station 4000see related information
Date Initiated by FirmApril 15, 2024
Date PostedMay 30, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1932-2024
Recall Event ID 94527
Product Classification Cabinet, table and tray, anesthesia - Product Code BRY
ProductBD Pyxis(TM) Anesthesia Station 4000, REF: 338
Code Information UDI: 10885403477829/ Serial Numbers: 15798662 15810061 15810065 15817562 15817565 15835217 15835218 15835220 15835221 15835222 15835223 15835224 15835225 15842733 15861006 15861007 15867540 15873126 15918237 15924975 15924976 15924977 15931453 15931454 15931455 15931456 15931457 15931458 15931459 15931460 15931461 15931462 15931463 15931464 15937528 15937529 15937530 15937531 15939257 15939258 15939259 15939260 15939957 15939958 15939960 15939961 15939962 15939963 15939964 15939965 15939966 15939967 15939968 15990642 15991836 15991837 16003697 16012922 16012923 16012924 16012925 16012926 16012927 16012928 16012929 16016868 16040839 16051442 16057728 16058994 16060051 16060052 16060053 16060054 16060055 16060056 16060057 16060058 16060048 16060966 16060962 16085461 16085475 16085476 16085477 16085478 16085479 16085480 16085481 16085482 16085483 16085484 16085485 16203788 16389146 13946913 14186949 14394813 14571778 14680456 14738938
Recalling Firm/
Manufacturer
CareFusion 303, Inc.
10020 Pacific Mesa Blvd
San Diego CA 92121-4386
Manufacturer Reason
for Recall
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
FDA Determined
Cause 2
Component design/selection
ActionOn May 2, 2024, CareFusion, a subsidiary of Becton, Dickinson and company issued a "Urgent Medical Device Correction", to affected consignees via Fed-Ex by 2-day mail and email. CareFusion ask consignees to take the following actions: 1. If fluid spills in or near the BD Pyxis" MedStation" or BD Pyxis"Anesthesia Station, clean it up immediately. Divert the spilled liquid from any seams or openings. 2. In the event of an accidental fluid spill on the system or in a drawer: A. Stop use of the device B. Immediately remove power to the device (unplug from the wall) C. Quarantine the device and notify BD service personnel at 1-800-727-6102 D. If smoke or fire occurs, determine if healthcare workers and patients need to be distanced or evacuated, and follow internal policies and procedures. E. Follow facility downtime policies and procedures to obtain medications needed for patient care. 3. Per BD Pyxis" MedStation" labeling, never store or place liquids on the station. It is recommended to not overfill drawers; use drawer liners and store items containing liquids in the bottom of the BD Pyxis" MedStation" 4000 and BD Pyxis" MedStation" ES devices to minimize potential fluid ingress to the entire device. 4. It is best practice to have monitoring of the environment with automated smoke/fire alarms and sprinkler systems to extinguish any fire. Downtime policies and procedures should include a process for obtaining medications from another device or from pharmacy during downtime. 5. Appendix A provides updated Warnings, Cautions and recommendations regarding fluid ingress. Please post Appendix A to all Pyxis" MedStation" and Pyxis" Anesthesia Stations until updated Safety Guides are available. 6. Please circulate this notice to all those who require awareness within your organization or to any organization whom you may have transferred BD Pyxis" MedStation or BD Pyxis" Anesthesia Station devices to. 7. Complete the attached Customer Response Form and return to the BD c
Quantity in Commerce102 units
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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