| Class 2 Device Recall BD Pyxis MedStation 4000 7Drawer Auxiliary Tower |  |
Date Initiated by Firm | April 15, 2024 |
Date Posted | May 30, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1930-2024 |
Recall Event ID |
94527 |
Product Classification |
Cabinet, table and tray, anesthesia - Product Code BRY
|
Product | BD 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
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12881598
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12595252
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12888320
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12903357
12904180
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12824214
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12895929
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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
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12858810
8000106736
8000129582
8000129583
8000129584
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8000037329
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13215907
8000105113
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8000101754
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8000061481
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8000028939
8000116781
8000118212
8000098329
13347772
13350124
13393080
13393082
13393086
13461313
13461289
13462253
13462255
13462256
13462259
13467815
13469644
13527058
13527060
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13588075
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13714429
13720774
13741625
13781581
13781582
13792361
13792365
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13928000
13928002
13930177
13930178
13933824
13979865
13985500
14030769
14153251
14153252
14160242
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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 |
Action | On 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 Commerce | 369 units |
Distribution | 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. |
Total Product Life Cycle | TPLC Device Report |
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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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