Z-2249-2018Class II

Drainer(R) Centesis Catheters: (a) REF 8810, 5F x 9cm (b) REF 8811, 6F x 9cm (c) REF 8812, 5F x 15cm Product...

Name: 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...
Creator: Vascular Solutions, Inc.
Published: 2018-05-04
License: https://open.fda.gov/license/

Vascular Solutions LLC / initiated 2018-05-04 / Terminated / root cause: sterility

FDA source

Vascular Solutions, Inc. began a recall of 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... on 2018-05-04. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-2249-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-04
Posted: 2018-06-18
Terminated: 2020-10-05
Recalling firm: Vascular Solutions LLC
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.
Product code: KGZ Accessories, Catheter
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.
Root cause tag: sterility
FDA root cause: Other
Action: Galt Medical Corp. sent an Urgent Medical Device Recall dated May 2, 2018 to affected customers. The letter identified the affected product, problem and actions to be taken. The firm requested the following actions be taken: Those with affected stock, were directed to immediately discontinue use and quarantine any product. If the affected product was further distributed, the distributor was directed to immediately contact all parties who may have received the affected stock and recover any unused product. For questions contact your local sales representative or Recall Coordinator at 214-778-1306 or email [email protected]
Quantity in commerce: 276 units
Distribution: US Nationwide Distribution
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2249-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2249-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-27	2018-06-18

Product code KGZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)