Z-2498-2024Class II
BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P, REF: 169-93 containing software version 3.9.1.9
CareFusion 303, Inc / initiated 2024-06-24 / Open, Classified / root cause: labeling and UDI
CareFusion 303, Inc. began a recall of BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P, REF: 169-93 containing software version 3.9.1.9 on . FDA classified it as Class II and gives the reason as "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". As of , the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.
Recall record
- Recall number
- Z-2498-2024
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- CareFusion 303, Inc
- Product
- BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P, REF: 169-93 containing software version 3.9.1.9
- Product code
- BRY Cabinet, Table And Tray, Anesthesia
- 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.
- Root cause tag
- labeling and UDI
- FDA root cause
- Under Investigation by firm
- Action
- On 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 commerce
- 6 units
- Distribution
- US 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.
- Product codes and lots
- UDI: 10885403512568/ Serial Number: 16091819 15925591 15927975 15935627 15561266 16158516
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2485-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2486-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2487-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2488-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2489-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2490-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2491-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2492-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2493-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2494-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2495-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2496-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2497-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2498-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2499-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2500-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2501-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2502-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2503-2024 | Class II | Ongoing | Voluntary: Firm initiated |
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