Z-1372-2016Class II

HLS Set Advanced with BIOLINE Coating Custom tubing packs for the oxygenator

Name: Z-1372-2016 HLS Set Advanced with BIOLINE Coating Custom tubing packs for the oxygenator
Creator: Maquet Cardiovascular Us Sales, Llc
Published: 2016-02-23
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2016-02-23 / Terminated / root cause: sterility

FDA source

Maquet Cardiovascular Us Sales, Llc began a recall of HLS Set Advanced with BIOLINE Coating Custom tubing packs for the oxygenator on 2016-02-23. FDA classified it as Class II and gives the reason as "Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products". 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-1372-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-23
Posted: 2016-04-12
Terminated: 2019-09-25
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: HLS Set Advanced with BIOLINE Coating Custom tubing packs for the oxygenator
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products.
Root cause tag: sterility
FDA root cause: Unknown/Undetermined by firm
Action: The firm, Maquet Inc., sent an "URGENT MEDICAL DEVICE RECALL" Letter/Response Form dated 2/23/2016 via Fed Ex to their customers. The letter describes the product, problem and actions to be taken. The customers were instructed to review the list to determine if you have the affected products; monitor patients for signs; monitor and treat signs according to your protocols and clinical judgments; support shock symptoms and maintain circulatory and hemodynamics per your facility's protocol and care guidelines, and complete and and return the enclosed Response Form by email to: [email protected] or fax to: 1-973-629-1518 within three (3) business days. For any questions, please contact your Maquet sales and representative or Maquet Customer Service at 1-888-627-8383 (press option 2, followed by option 2) Monday through Friday, between the hours of 8:00am and 6:00pm EST.
Quantity in commerce: 72,000 units in total
Distribution: US Nationwide Distribution.
Product codes and lots: HLS Set Advanced: Small Adult 5.0 with BIOLINE Coating BEQ-HLS 5050, 70105.2797, Adult 7.0 with BIOLINE Coating BEQ-HLS 7050, 70105.2794 and Adult 7.0 with SOFTLINE Coating BO-HLS 7050, 70105.2786

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1372-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1371-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-12
Z-1372-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-12
Z-1373-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-12
Z-1374-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-12

Product code DTQ

K102726Class IICardiohelp SystemMaquet Cardiopulmonary, AG / cleared 2011-04-04

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)