# FDA recall Z-1540-2024

> **Smiths Medical ASD Inc.** · Class II · device recall initiated 2023-12-19.

## Product

Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers:    a) 3500  b) 3500-0600-00  c) 3500-0600-01  d) 3500-0600-249  e) 3500-0600-50  f) 3500-0600-51  g) 3500-0600-82  h) 3500-306  i) 3500-402  j) 3500-414  k) 3500-415  l) 3500-500  m) 3500E  n) 3500VX-306  o) 3500VX-500

## Reason for recall

Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a molding defect that could potentially lead to slippage of the spring within the barrel clamp assembly. If this occurs, it could result in the inability of the pump to recognize a syringe or the pump may misidentify the size of the syringe loaded.

## Distribution

Worldwide distribution.

## Key facts

- **Recall number:** Z-1540-2024
- **Recalling firm:** Smiths Medical ASD Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-12-19
- **Report date:** 2024-04-24

- **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-1540-2024

## Citation

> AI Analytics. FDA recall Z-1540-2024. Retrieved 2026-06-14 from https://api.ai-analytics.org/recall/Z-1540-2024. Source: US FDA. Licensed CC0.

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