FDA recall Z-1271-2022

Product

Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

Reason for recall

Multiple issues with the potential for interruption of therapy or over-infusion: 1. Primary Audible Alarm (PAA), 2. Unanticipated Depleted Battery Alarms, 3. Time Base Alarm, 4. Intermittent Volume Over Time (IVOT) - Infusion Continues after System Failure, 5. Clearing of Program Volume Delivered (PVD), 6. False Alarm for Rate Below Recommended Minimum for Syringe Size, 7. Incorrect Bolus or Loading Dose Time Display, 8. Domain Name Server (DNS) Port 1001

Distribution

Worldwide distribution. US nationwide including US Virgin Islands, Countries of: AE, AL, AT, AU, BE, BM, BN, BS, CA, CH, CL, CY, CZ, DE, DK, DO, ES, FI, FR, GB, HK, HU, ID, IE, IL, IN, IR, IT, KR, KW, LB, LK, MU, MX, MY, NL, NZ, OM, PA, PH, PK, PL, PT, QA, SA, SE, SG, TR, TT, VI, and VN.

Key facts

Status

Ongoing

Initiation date

2022-04-18

Report date

2022-06-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1271-2022