Open, Classified

BD Pyxis CII Safe ES, REF: 1116-00

FDA Recall Z-0672-2025 · Posted 2024-12-11

Recall StatusOpen, Classified

Product CodeBRY

Date Initiated2024-11-14

Product Quantity218

Reason for Recall

Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or position, which can lead to: 1) Unintended and incorrect medication removal, or 2) Potential for a different medication (medication pulled in error) to be refilled/loaded, which may lead to may lead to low inventory or a stockout.

Firm Action

On 11/14/24, correction notices were mailed/emailed to customers: Devices can continue to be used in accordance with the following: Best practice is for providers (e.g., nurses) to verify the medication being removed is accurate against the hospital patient record (source of truth) prior to administration1. o Labeling includes the following warning: Always utilize the BD Pyxis ES System patient/order information in conjunction with the medical record when making clinical decisions. Making clinical decisions solely from System information may result in errors in care resulting in serious injury or death. " To further aid that verification step, it has been estimated that BCMA (Barcode Medication Administration) can reduce medication administration errors. Similarly, "Scan on Remove" functionality can be enabled within the MedStation to help capture an erroneously dispensed medication. " Safe storage and labeling for neuromuscular blocking (NMB) agents - Institute for Safe Medication Practices (ISMP) recommends to segregate, sequester, and differentiate NMBs from other medications. This can help identify a high-risk medication is being removed in error. " If a different medication is dispensed, the error may be caught during the check process prior to leaving the pharmacy. If error is not caught, pharmacy technician will still refill/load the medication dispensed properly at the device. " ES server includes notifications for those medication pockets that are empty within the System to trigger pharmacy to refill. Complete and return response form to [email protected] For further assistance, contact firm: Technical Support - 1-800-727-6102, 24 hours, 7 days a week; Regional Complaint Center, 1-844-823-5433, Mon-Fri 8:00am-5:00pm CT, [email protected]; Post Market Quality Operations, Fax: 1-410-316-4258, Email: [email protected] On 2/6/2025, updated correction notices were sent notifying customers that the firmware update was available.

Root Cause

Software design

Distribution Pattern

Worldwide - US Nationwide distribution including in the states of OK, LA, FL, AR, VA, KY, PA, AL, NC, CA, MN, AK, TX, MI, ME, OH, OR, NY, IL, RI, GA, WI, NH, KS, CO, WA, MO, MD, AZ, SC, NV, WV, NM, IN, NJ, TN, DE, MT, MA, VT, DC, NE, CT, ID, WY, MS, UT, HI, IA, SD, ND, GU, MP, PR and the countries of CA, BR, JP, ES, NZ, AU, FR, AR, MX, IT, CL, TR, SA, MY, CH, IE, TH, SG, KW, BE, DE, PT, QA, MA, FI, AE, EG, BS, GB, BM, GR, BH, KR, MC, PL, LB, HK, IN, IL, MO, IQ, TN, NO, PH, CO, TW, CN, JO, OM.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.