Z-2401-2010

Maquet HLM Tubing Pack; Bioline Coating

Name: Z-2401-2010 Maquet HLM Tubing Pack; Bioline Coating
Creator: Maquet Inc.
Published: 2010-07-13
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2010-07-13 / Terminated / root cause: manufacturing process

FDA source

Maquet Inc. began a recall of Maquet HLM Tubing Pack; Bioline Coating on 2010-07-13. The reason FDA records is "The color of the tape on the arterial and the venous line were placed incorrectly, causing the connection of the arterial and the venous lines to be interchanged". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2401-2010
Status: Terminated
Initiated: 2010-07-13
Posted: 2010-09-12
Terminated: 2011-08-10
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: Maquet HLM Tubing Pack; Bioline Coating
Product code: DWE Tubing, Pump, Cardiopulmonary Bypass
Reason for recall: The color of the tape on the arterial and the venous line were placed incorrectly, causing the connection of the arterial and the venous lines to be interchanged.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Recall notification letters were sent by Federal Express on July 13, 2010 to affected account and also an e-mail to the Maquet field representative who services the account.
Quantity in commerce: 5 units
Distribution: Distribution: Pennsylvania
Product codes and lots: Product number BEQ-TOP 14801; lot numbers 70040244, 70046759.

Product code DWE

K053025Class IIJostra Hlm Tubing SetMaquet Cardiopulmonary, AG / cleared 2005-11-10

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)