Z-2002-2016Class II

Small Patient ECC Pack, REF BEQ-TOP 24100

Name: Z-2002-2016 Small Patient ECC Pack, REF BEQ-TOP 24100
Creator: Datascope Corporation
Published: 2016-05-09
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2016-05-09 / Terminated / root cause: sterility

FDA source

Datascope Corporation began a recall of Small Patient ECC Pack, REF BEQ-TOP 24100, Product Usage: The HLM Tubing Sets with Bioline Coating are for single use only. They may be sold sterile... on 2016-05-09. FDA classified it as Class II and gives the reason as "Custom Tubing Set BEQ-TOP-24100 (Small Patient ECC Pack) was identified as possessing a level of endotoxin that exceeded the regulatory limits". 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-2002-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-09
Posted: 2016-06-15
Terminated: 2017-03-28
Recalling firm: Datascope Corp.
Product: Small Patient ECC Pack, REF BEQ-TOP 24100, Product Usage: The HLM Tubing Sets with Bioline Coating are for single use only. They may be sold sterile, non-sterile and bulk packed. Custom tubing sets that are sold sterile are not to be re-sterilized by the user. In open heart surgery the HLM Tubing Sets with Bioline Coating are used in combination with the heart-lung machine for the oxygenation of blood and removal of carbon dioxide. The main purpose of the HLM Tubing Sets with Bioline Coating is to connect the patient to the hear-lung machine and its components. The HLM Tubing Sets with Bioline Coating are therefore a component in the extracorporeal perfusion circulation system. The utilization period of the use of the tubing sets is restricted to six hours
Product code: DWE Tubing, Pump, Cardiopulmonary Bypass
Reason for recall: Custom Tubing Set BEQ-TOP-24100 (Small Patient ECC Pack) was identified as possessing a level of endotoxin that exceeded the regulatory limits.
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: Maquet sent via express mail and hand delivered a recall letter and response form dated May 9, 2016 to their sole customer.
Quantity in commerce: 17 units
Distribution: US in the state of GA
Product codes and lots: Lot/batch No: 3000003260, Part number 701050175

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2002-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2002-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-15

Product code DWE

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