Recall record at a glance
| Official record | Z-1375-2025 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | CareFusion 303, Inc. |
| Report date | Mar 26, 2025 |
| Recall initiation date | Feb 6, 2025 |
| Quantity | 727 |
| Location | San Diego, CA, United States |
Official product description
BD Pyxis: Anesthesia Station ES, REF: 327, MedStation ES, REF: 323, MedStation ES Tower, REF: 352, CII Safe ES, REF: 1116-00, CII Safe ES Desktop PC, REF: 1156-00, CII Safe ES Desktop PC, Wired SCNR, REF: 107-254-01, CII Safe ES Desktop PC, W-less SCNR, REF: 107-255-01, Used with Enterprise Server (ES), REF: 1115-00 with affected Enterprise Server software.
Why the product was recalled
Sync timeout may occur between the server and automated dispensing device, due to a server software error which may occur if syncing a large amount of data that takes excessive time, which may cause the dispensing devices to become disconnected from the ES server; dispensing devices will not receive updated information, which may lead to incorrect therapy, and delay in accessing medication.
Distribution information
Worldwide - US Nationwide distribution including in the states of KY, OH, NY, MO, NC, PA, FL, TN, CT, LA, MN, VA, MD, CA, TX, NE, IA, OK, MI, PR, SD, IN, ME, KS, IL, NM, WA, AR, HI, MS, GA, WY, WI, VT, AL, NV, NJ, DC, AZ, MT, AK, OR, CO, NH, MA, SC, ID, UT, ND and the countries of TW, CA, AE, MX, SG, AU, NZ, GB, CH, BH.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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