Recall Z-2249-2018— Vascular Solutions, Inc.
Class II · Terminated
Class II FDA medical device recall by Vascular Solutions, Inc., initiated 2018-05-04, terminated 2020-10-05. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: 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..
- Recalling firm
- Vascular Solutions, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-05-04
- Terminated
- 2020-10-05
- Firm location
- Maple Grove, MN, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.