Z-2249-2018 Class II Terminated
FDA device recall Z-2249-2018 was initiated by Vascular Solutions, Inc. on May 4, 2018 and is designated Class II. 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. The recall status is terminated (terminated October 5, 2020). Affected quantity: 276 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 27, 2018
- Initiation Date
- May 4, 2018
- Termination Date
- October 5, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 276 units
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.
Distribution Pattern
US Nationwide Distribution
Code Information
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