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RecallWatchMedical Device Safety
Class IIOngoingZ-1050-2025

CareFusion 303, Inc. recalls BD Pyxis MedStation ES AUX Tower REF 343 BD Pyxis " MedStation 4000 AUX Tower REF 31…

CareFusion 303, Inc.San Diego, CA, United StatesReported Feb 5, 2025 · 1 year ago
Legal News Analyst ·

Reason for recall

Due to an increase in complaints of door latch assembly failures that may cause the doors to be left in an open state potentially causing inventory discrepancies, a delay in access to medication and/or diversion of medication.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

BD Pyxis MedStation ES AUX Tower REF 343 BD Pyxis " MedStation 4000 AUX Tower REF 314 The BD Pyxis" MedStation ES and Pyxis" MedStation 4000 are automated dispensing cabinets (ADC) that are intended to securely store and dispense medications to a qualified and authorized healthcare provider.

Lot / code information

Catalog #
343
UDI
code: 10885403512698
Serial #
Equipment Number: 14535900 14535900 14535901 14535901 14535902 14535902 14535903 14535903 14535904 14535904 14535905 14535905 14535906 14535906 14535907 14535907 14535908 14535908 14535910 14535910 14…Show all
Equipment Number: 14535900 14535900 14535901 14535901 14535902 14535902 14535903 14535903 14535904 14535904 14535905 14535905 14535906 14535906 14535907 14535907 14535908 14535908 14535910 14535910 14535912 14535912 14535913 14535913 14535916 14535916 14535919 14535919 14535922 14535922 14535924 14535924 14535926 14535926 14535928 14535928 14535930 14535930 14535932 14535932 14535934 14535934 14535936 14535936 14535937 14535937 14535939 14535939 14535941 14535941 14535943 14535943 14535945 14535945 14535947 14535947 14535949 14535949 14535951 14535951 14535953 14535953 14535954 14535954 14535956 14535956 14535958 14535958 14535960 14535960 14535962 14535962 14535964 14535964 14535966 14535966 14549572 14549572 14549573 14549573 14549574 14549574 14549575 14549575 14549576 14549576 14549577 14549577 14651270 14651270 14651271 14651271 14651282 14651282 14651297 14651297 14651298 14651298 14651299 14651299 14651314 14651314 14651315 14651315 14651316 14651316 14651317 14651317 14651357 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161523 …
Additional code information

14935325 14935326 14935326 14935327 14935327 14935328 14935328 14935329 14935329 14935330 14935330 14935331 14935331 14935332 14935332 14935333 14935333 14935334 14935334 14935335 14935335 14935336 14935336 14938306 14938306 14938308 14938308 14938311 14938311 14938312 14938312 14938313 14938313 14938316 14938316 14938318 14938318 14938319 14938319 14950346 14950346 14959036 14959036 14959037 14959037 14959038 14959038 14959040 14959040 14959041 14959041 14959043 14959043 14965752 14965752 13762887 13762887 14554050 14554050 14777378 14777378 12710759 12710759 12740196 12740196 12792469 12792469 12795040 12795040 12797779 12797779 12817211 12817211 8000065399 13242033 8000065400 13242043 8000065401 13242053 8000065402 13242063 8000065403 13242073 8000083690 13250020 8000116118 13270132 8000116119 13270142 14092740 14092740 14092741 14092741 14680400 14680400 14928003 14928003 14928007 14928007 13765610 13765610 14867572 14867572 14463678 14463678 13765609 13765609 12795759 12795759 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14354735 14354738 143547 …

What the firm is doing

On 02/14/2023 and 01/09/2024, the firm sent an "Urgent Medical Product Advisory" letter to customers informing them that BD was made aware due to an increase in customer complaints for AUX Tower Door Latch assembly failures. The latch failure can leave the door in an open state, potentially causing inventory discrepancies (including billing), a delay in access to medication and/or diversion of medication. Customers were instructed: 1. May continue to use these devices as intended and should file a complaint via the Customer Portal at https://www.bd.com/self-service or call BD Support at 1-800-727-6102, should you experience drawer or door failures. 2. If customers experience delays in access to medication due to a drawer or door failure, ensure backup procedures (which may include but may not necessarily be limited to keys, emergency medication supplies, alternate devices in proximity, etc.) are in place and staff have all been properly trained on them. 3. Promptly complete and return the enclosed Customer Response Form to acknowledge receipt of this notification and that you understand the information provided in this letter. For Distributors: 1. Provide a copy of this notification to any customers who may have received products listed in the Affected Products table above. 2. Promptly complete and return the enclosed Customer Response Form to acknowledge receipt of this notification and that you understand the information provided in this letter. For questions - contact 1-866-583-8783 Actions Taken by BD for Door Latch Failure: 1. Revised BD Pyxis Field Service Guide to include the use of a conductive contact enhancer that will help prevent corrosion and increase connectivity to the latch thus significantly reducing door failures. 2. Updating the door latch design. 3. If Auxiliary Tower Door failure occurs due to poor connection, BD will provide service support to evaluate and resolve the issue.

DistributionShow details

U.S.: 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, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. O.U.S.: Germany and Japan

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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