Z-0178-2015Class II

Cardiopulmonary bypass connector; P/N: 321334-000 DESC: CONNECTOR, 3/8 X 3/8 X 1/2 CLEAR PAY LOT: 295424...

Name: Z-0178-2015 Cardiopulmonary bypass connector; P/N: 321334-000 DESC: CONNECTOR, 3/8 X 3/8 X 1/2 CLEAR PAY LOT: 295424...
Creator: Dokitz NovoSci
Published: 2014-09-18
License: https://open.fda.gov/license/

Novosci Corp / initiated 2014-09-18 / Terminated / root cause: manufacturing process

FDA source

Dokitz NovoSci began a recall of Cardiopulmonary bypass connector; P/N: 321334-000 DESC: CONNECTOR, 3/8 X 3/8 X 1/2 CLEAR PAY LOT: 295424 STERILE Expiration May 2019 Manufacturing Date May 2014 on 2014-09-18. FDA classified it as Class II and gives the reason as "The single leg of the PAY connector has been observed to become detached". 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-0178-2015
Classification: Class II
Status: Terminated
Initiated: 2014-09-18
Posted: 2014-11-06
Terminated: 2015-05-15
Recalling firm: Novosci Corp
Product: Cardiopulmonary bypass connector; P/N: 321334-000 DESC: CONNECTOR, 3/8 X 3/8 X 1/2 CLEAR PAY LOT: 295424 STERILE Expiration May 2019 Manufacturing Date May 2014
Product code: DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Reason for recall: The single leg of the PAY connector has been observed to become detached.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The recalling firm notified the affected customers via letter and requested the affected lot be returned to NovoSci.
Quantity in commerce: 240 units
Distribution: MO, TX, PA, IL, MD, UT
Product codes and lots: Model No. 321334-000, lot number 295424

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0178-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0178-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-12	2014-11-06

Product code DTL

K801404Class IIDisposable Parallel Y ConnectorsTexas Medical Products, Inc. / cleared 1980-06-30

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)