FDAFDA · Food and drugs·Recall number Z-2249-2018
Drainer(R) Centesis Catheters: (a) REF 8810, 5F x 9cm (b) REF 8811, 6F x 9cm (c) REF 8812, 5F x 15cm Product The Drainer centesis catheter is intended for use in percutaneous fluid aspirations and small volume drainage procedures.
Published June 27, 2018 · Recall initiated: May 4, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The supplier of Drainer(R) centesis catheters notified Vascular Solutions, Inc. that there is a potential for certain production lots to contain unsafe levels of bacterial endotoxins.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Vascular Solutions, Inc.
- Distributor
- US Nationwide Distribution
- Lot
- a) REF 8810, 5F x 9cm, Lot Numbers: 18037128, 18057123 (b) REF 8811, 6F x 9cm, Lot Numbers: 18026062, 18026063 (c) REF 8812, 5F x 15cm, Lot Number: 18050076
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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