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

Recall Z-0583-2017 — Atrium Medical 32 Fr Trocar catheter, Sterile Model Number: 8432 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.

U.S. FDA — Device Enforcement · United States · 2016-10-26 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0583-2017
Date of alert: 2016-10-26
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Atrium Medical Corporation
Product category: device
Product type: Devices

Reported risk: Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.

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-0583-2017 — Atrium Medical 32 Fr Trocar catheter, Sterile Model Number: 8432 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.

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