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

Recall Z-1124-2020 — Prometra Programmable 20mL Pump. Catalog No. 91827 The device is an implantable infusion pump. GTIN-14 00810335020XXX (XXX = in-country language specific)

U.S. FDA — Device Enforcement · United States · 2019-12-24 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1124-2020
Date of alert: 2019-12-24
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Flowonix Medical Inc
Product category: device
Product type: Devices

Reported risk: A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm tone in certain "out of tolerance" conditions associated with the pump's valve system.

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.

Recall Z-1124-2020 — Prometra Programmable 20mL Pump. Catalog No. 91827 The device is an implantable infusion pump. GTIN-14 00810335020XXX (XXX = in-country language specific)

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