Z-0093-2024 Class II Ongoing
FDA device recall Z-0093-2024 was initiated by CareFusion 303, Inc. on September 6, 2023 and is designated Class II. Reason for recall: When global edit is used to update multiple formulary properties simultaneously, the following properties: 1) Require Lot Number on Recall, 2) Access Destruction Bin (Witness), 3) Add to Destruction B… The recall status is ongoing. Affected quantity: 61.
Recall Details
- Product Type
- Devices
- Report Date
- October 18, 2023
- Initiation Date
- September 6, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 61
Product Description
BD Pyxis CII Safe ES, REF: 1116-00; and BD Pyxis : CII Safe ES Desktop PC, Wired SCNR, REF: 107-254-01; CII Safe ES Desktop PC, W-LESS SCNR, BIO, REF: 107-255-01; Enterprise Server, REF: 1115-00, 134157-01, 137670-02, 134148-01, 135292-01, 136449-01, 133760-01
Reason for Recall
When global edit is used to update multiple formulary properties simultaneously, the following properties: 1) Require Lot Number on Recall, 2) Access Destruction Bin (Witness), 3) Add to Destruction Bin (Count/Empty), 4) CII Safe Stock Out Notice are, without user warning, overwritten to the value NO , which could result in diversion of controlled substances from the automated dispensing cabinet.
Distribution Pattern
US Nationwide distribution in the states of LA, NC, NY, MI, MA, NV, KS, IA, CA.
Code Information
REF: 1116-00, UDI-DI: 10885403512605. Software Versions: 1.7.3 and 1.7.4 (Limited commercial release)