# FDA recall Z-1272-2022

> **Smiths Medical ASD Inc.** · Class I · device recall initiated 2022-04-18.

## Product

Medfusion Syringe Pump Models:  3500, 3500-0600-00, 3500-0600-01, 3500-0600-249, 3500-0600-50, 3500-0600-51, 3500-0600-82, 3500-306, 3500-402, 3500-414, 3500-415, 3500-500, 3500BC, 3500E, 3500G, 3500SD, 3500SD-500, 3500VX, 3500VX-306, 3500VX-414, 3500VX-415, 3500VX-500, 3500ZE, Software Versions 6.0.0, 6.0.1

## 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

- **Recall number:** Z-1272-2022
- **Recalling firm:** Smiths Medical ASD Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-04-18
- **Report date:** 2022-06-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Minneapolis, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1272-2022

## Citation

> AI Analytics. FDA recall Z-1272-2022. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-1272-2022. Source: US FDA. Licensed CC0.

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