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

Recall Z-2561-2021 — Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000

U.S. FDA — Device Enforcement · Germany · 2021-06-18 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2561-2021
Date of alert
2021-06-18
Country / jurisdiction
Germany
Risk level
Class II
Risk type
recall
Brand
WOM World of Medicine AG
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
72205000
Reported risk: When the display of inflow volume to the uterus reaches 32450 ml, the fluid management system control unit display will freeze because the internal software calculation threshold is reached. The outflow measurement will continue, and so the deficit accumulated up to this point will start counting backwards to 0 ml. There is a risk of distention fluid reaching the soft tissue circulatory 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.