Z-1769-2017Class II

Custom Tubing Pack with Bioline Coating UDI code: 00607567208230 Part Number: 709000058 The HLM Tubing Sets...

Name: Z-1769-2017 Custom Tubing Pack with Bioline Coating UDI code: 00607567208230 Part Number: 709000058 The HLM Tubing Sets...
Creator: Datascope Corporation
Published: 2017-02-16
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2017-02-16 / Terminated / root cause: design

FDA source

Datascope Corporation began a recall of Custom Tubing Pack with Bioline Coating UDI code: 00607567208230 Part Number: 709000058 The HLM Tubing Sets with Bioline Coating are for single use only. They... on 2017-02-16. FDA classified it as Class II and gives the reason as "A complaint was received on January 1, 2017 stating the pigtail on line 2 of the oxygenator was assembled to the port where the yellow cap and the clear cap remained on the center port". 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-1769-2017
Classification: Class II
Status: Terminated
Initiated: 2017-02-16
Posted: 2017-03-23
Terminated: 2019-03-21
Recalling firm: Datascope Corp.
Product: Custom Tubing Pack with Bioline Coating UDI code: 00607567208230 Part Number: 709000058 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 heart-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. The Bioline Coating improves the physical surface properties of products for the extracorporeal circulation system.
Product code: DWE Tubing, Pump, Cardiopulmonary Bypass
Reason for recall: A complaint was received on January 1, 2017 stating the pigtail on line 2 of the oxygenator was assembled to the port where the yellow cap and the clear cap remained on the center port.
Root cause tag: design
FDA root cause: Device Design
Action: Maquet Inc. was notified by their customer on January 1, 2017. This was a reverse notification. The one impacted customer said they will not return the product since they can easily correct the pigtail connection before use. For further questions regarding this recall, please call (973) 709-7442.
Quantity in commerce: 21 kits
Distribution: US Distribution to the state of : CA.
Product codes and lots: Lot number 3000033848

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1769-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1769-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-19	2017-04-10

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