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

Recall Z-2804-2017 — Syringe Bulb, 60 CC 50 pcs per case. The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function

U.S. FDA — Device Enforcement · United States · 2017-06-23 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2804-2017
Date of alert: 2017-06-23
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: International Medsurg Connection, Inc.
Product category: device
Product type: Devices

Reported risk: Insufficient documentation to support product sterility claims.

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

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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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