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U.S. Department of Health and Human Services

Class 2 Device Recall BD Pyxis MedStation 4000 7Drawer Auxiliary Tower

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 Class 2 Device Recall BD Pyxis MedStation 4000 7Drawer Auxiliary Towersee related information
Date Initiated by FirmApril 15, 2024
Date PostedMay 30, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1930-2024
Recall Event ID 94527
Product Classification Cabinet, table and tray, anesthesia - Product Code BRY
ProductBD Pyxis MedStation 4000 7-Drawer Auxiliary Tower, REF: 306
Code Information UDI: 10885403512636/ Serial Numbers: 15788716 15788766 15789401 15789402 15791695 15792207 15792210 15798754 15813793 15813794 15835152 15835154 15835156 15845636 15852321 15854270 15854271 15854272 15854273 15854882 15855486 15855995 15856110 15856109 15856180 15856933 15856934 15856953 15856955 15856957 15856939 15856941 15857842 15857846 15857847 15857848 15857849 15857850 15857851 15857852 15858073 15858075 15859399 15860312 15860313 15860422 15860424 15860425 15860427 15860932 15863161 15863163 15863158 15863184 15863185 15863189 15863186 15863188 15864816 15866021 15868996 15869276 15869278 15869280 15869444 15869445 15869446 15869448 15869449 15869451 15869454 15869457 15869460 15895368 15905075 15907775 15907776 15910452 15910453 15910454 15910455 15910456 15910457 15918235 15918236 15920351 15921886 15924489 15924490 15924491 15925085 15925086 15928628 15928629 15930186 15930187 15932256 15932257 12996853 12996854 12996876 8000124804 15934607 15934608 15934656 15935239 15935240 13179329 13179331 13181837 13181838 13181839 13181840 13181841 13204213 13207459 13211148 13214385 13214386 13214387 13214388 15937821 15942624 15945070 15945071 15945745 15949851 15951203 15954768 15958166 15960803 15961967 15984871 15984872 15984874 16001214 16001218 16004399 16004400 16004401 16052917 16062303 16069684 16079413 13176356 16173446 12881569 710121947 13216869 12886587 13137828 12894386 12894387 12894388 12894389 12894390 12894391 12702061 12702062 12702081 12702110 12704168 12682952 8000130572 8000131571 8000035833 8000115246 12794336 12794469 12806570 12806571 12815157 8000001026 13022216 12712277 12712830 12881598 12918868 8000117679 13026785 710166694 12595252 12697630 12697633 12703855 8000018625 8000080392 8000080505 12888319 12888320 12888321 12888322 12888323 12888324 12888325 12888599 12888656 12901578 12901579 12895380 12902487 12903356 12903357 12904180 12836254 12824214 12895927 12895929 12895931 12905668 12922022 8000068458 8000078086 8000078089 8000078090 8000078093 8000078094 8000082404 8000099694 8000099695 710008244 710024678 710024679 710051515 8000024201 8000067871 9304700 8000004555 8000004704 8000132198 12978790 13008201 13008205 13058928 13077659 710099037 710100576 710101030 710110161 12568591 12690138 8000116771 8000119353 8000119354 9418568 12858808 12858810 8000106736 8000129582 8000129583 8000129584 8000037326 8000037327 8000037328 8000037329 8000037478 8000058226 8000058234 12524687 12626539 12681705 12686454 12828922 13139998 12613253 12470354 12490126 12490127 12549048 12605978 12701912 12708903 12786826 12853617 12881198 12885265 12990238 12990240 13047497 13074999 13088317 13096632 13124118 13125129 13146799 13147622 13150846 13158606 13165018 13172604 13181896 13192438 13193990 13207499 13215907 8000105113 8000011785 8000101754 8000049081 8000061481 8000116931 8000131412 8000113415 8000091123 8000028937 8000028939 8000116781 8000118212 8000098329 13347772 13350124 13393080 13393082 13393086 13461313 13461289 13462253 13462255 13462256 13462259 13467815 13469644 13527058 13527060 13580171 13588075 13597194 13714429 13720774 13741625 13781581 13781582 13792361 13792365 13859781 13928000 13928002 13930177 13930178 13933824 13979865 13985500 14030769 14153251 14153252 14160242 14507879 14557569 14662140 14689054 14753672 14849246 14877901 14900329 14951339 15046773 15079066 15079067 15101508 15101510 15103482 15169936 15202573 15222371 15328692 15481803 15622858 15720471
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 Commerce369 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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