Z-0011-2011

MAQUET HLM Tubing set with Bioline Coating (BEQ-TOP 21400 with 1/2 x 1/2 HG 0286 Connector; Device Part...

Name: Z-0011-2011 MAQUET HLM Tubing set with Bioline Coating (BEQ-TOP 21400 with 1/2 x 1/2 HG 0286 Connector; Device Part...
Creator: Maquet Inc.
Published: 2010-09-07
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2010-09-07 / Terminated / root cause: design

FDA source

Maquet Inc. began a recall of MAQUET HLM Tubing set with Bioline Coating (BEQ-TOP 21400 with 1/2 x 1/2 HG 0286 Connector; Device Part Number BEQ-TOP 21400 on 2010-09-07. The reason FDA records is "Tubing packs may contain defective 1/2 inch x 1/2 inch tubing connectors. Leaks at the shank of the connector may result in air aspiration in the venous line". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0011-2011
Status: Terminated
Initiated: 2010-09-07
Posted: 2010-10-06
Terminated: 2012-09-25
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: MAQUET HLM Tubing set with Bioline Coating (BEQ-TOP 21400 with 1/2 x 1/2 HG 0286 Connector; Device Part Number BEQ-TOP 21400
Product code: DWE Tubing, Pump, Cardiopulmonary Bypass
Reason for recall: Tubing packs may contain defective 1/2 inch x 1/2 inch tubing connectors. Leaks at the shank of the connector may result in air aspiration in the venous line.
Root cause tag: design
FDA root cause: Device Design
Action: Maquet Getigne Group issued Product Recall/Urgent Medical Device Corrective Action letters dated September 7, 2010 to customers, identifying the affected product, the issue prompting the recall, and actions to be taken by customers.Customers are to check their inventory for affected product. Customers with affected product are to contact Laura Olilver at 201-995-8849 for an RMA number and shipment instructions. All firms are to coomplete and return the Corrective Action Response Form. Maquet Customer Service can bre contacted at 800-777-4222.
Quantity in commerce: 22 items
Distribution: Worldwide Distribution: USA State of IL and country of the Netherlands.
Product codes and lots: Lot number 70052718 and 70048867

Product code DWE

K080592Class IIHlm Tubing Set with Bioline CoatingMaquet Cardiopulmonary, AG / cleared 2008-09-11

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)