The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2249-2018·Announced 2018-06-27

Vascular Solutions Recalls Drainer Centesis Catheters Due to Bacterial Endotoxins

Vascular Solutions, Inc. is recalling specific lots of Drainer Centesis Catheters because the supplier reported a potential for unsafe levels of bacterial endotoxins.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a potential for unsafe bacterial endotoxins, which poses a risk of harm, but the source text does not report any specific illnesses or injuries, fitting the High severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Vascular Solutions, Inc. is recalling specific lots of Drainer(R) Centesis Catheters. The recall involves 276 units of three reference numbers: 8810, 8811, and 8812. These medical devices are intended for use in percutaneous fluid aspirations and small volume drainage procedures.

The recall was initiated after the supplier notified Vascular Solutions, Inc. that certain production lots may contain unsafe levels of bacterial endotoxins. The affected lots are distributed nationwide in the United States.

Healthcare providers and facilities should stop using the affected catheters and contact Vascular Solutions, Inc. for further instructions. The specific lot numbers affected are 18037128 and 18057123 for REF 8810; 18026062 and 18026063 for REF 8811; and 18050076 for REF 8812.

The recalled product

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.
Manufacturer
Vascular Solutions, Inc.
Category
Medical Device — Catheters
Hazard
Affected units
276

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (9)

  • 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

Distribution

Distributed nationwide across the United States.

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