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U.S. Department of Health and Human Services

Class 2 Device Recall BD PYXIS MDBNK TWR MN

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 Class 2 Device Recall BD PYXIS MDBNK TWR MNsee related information
Date Initiated by FirmJune 24, 2024
Date PostedAugust 02, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2489-2024
Recall Event ID 94947
Product Classification Cabinet, table and tray, anesthesia - Product Code BRY
ProductBD PYXIS MEDBANK TWR MN CR-10HH-2FM-P, REF: 169-83 containing software version 3.9.1.9
Code Information UDI: 10885403512568/ Serial Number: 16210460 16191229 16227391 16260053 16055232 16102551
FEI Number 2016493
Recalling Firm/
Manufacturer		 CareFusion 303, Inc.
10020 Pacific Mesa Blvd
San Diego CA 92121-4386
For Additional Information ContactBD Customer Support
866-930-9251
Manufacturer Reason
for Recall		Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn July 11, 2024, CareFusion, subsidiary of Becton, Dickinson and Company (BD) issued a "Urgent Medical Device Correction" Notification, via mail. On June 24, 2024, BD issued Customer Release Notes via their firm's customer portal. BD ask consignees to take the following actions: Clinicians: 1. When restocking the cabinet, refer to the MedBank restock workflow screen to verify the correct bin location rather than the printed label until the software update is provided. Users should verify the contents of the bin location being restocked. 2. Please circulate this notice to all those who require awareness within your organization or to any organization whom you may have transferred BD Pyxis" MedBank" CUBIE" Replenishment Station devices to. 3. Please promptly complete and return the enclosed Customer Response Form within 15 days to acknowledge receipt of this notification and that you understand the information provided in this letter Distributor: 1. Please provide a copy of the attached customer letter to all facilities within your distribution network that have any product listed in Appendix 1. 2. Please promptly complete and return the enclosed Distributor Response Form within 15 days to acknowledge receipt of this notification and that you understand the information provided in this letter.
Quantity in Commerce6 units
DistributionUS Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV.
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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