Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1135-2018 — Medfusion Syringe Pump 3500 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2

U.S. FDA — Device Enforcement · United States · 2017-11-13 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1135-2018
Date of alert: 2017-11-13
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Smiths Medical ASD Inc.
Product category: device
Product type: Devices

Reported risk: Certain Medfusion Syringe Pump Models, Series 3100, 3500, and 4000, may not recognize or may misidentify loaded medication syringes. The inability of a pump to recognize a syringe (i.e. the size of the syringe is unknown to the pump) results in an inability to complete pump programming. Misidentification of a syringe is where the pump misinterprets the syringe size.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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