Z-1679-2017Class II

Non-Sterile Double DIN to DIN "Y" Connector

Name: Z-1679-2017 Non-Sterile Double DIN to DIN "Y" Connector
Creator: Molded Products Inc
Published: 2015-01-20
License: https://open.fda.gov/license/

Molded Products Inc / initiated 2015-01-20 / Terminated / root cause: manufacturing process

FDA source

Molded Products Inc began a recall of Non-Sterile Double DIN to DIN "Y" Connector, Product Usage: Extension for connecting hemodialysis blood tubing to the hemodialyzer on 2015-01-20. FDA classified it as Class II and gives the reason as "A customer relayed a complaint of a leaking dialysis tubing connector". 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-1679-2017
Classification: Class II
Status: Terminated
Initiated: 2015-01-20
Posted: 2017-03-24
Terminated: 2017-03-30
Recalling firm: Molded Products Inc
Product: Non-Sterile Double DIN to DIN "Y" Connector, Product Usage: Extension for connecting hemodialysis blood tubing to the hemodialyzer.
Product code: KOC Accessories, Blood Circuit, Hemodialysis
Reason for recall: A customer relayed a complaint of a leaking dialysis tubing connector.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 1/20/2015, the recalling firm requested the firm's customer to return units from the affected lot.
Quantity in commerce: 400 pieces
Distribution: Product was distributed to Ontario, Canada.
Product codes and lots: 40013

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1679-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1679-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-05	2017-03-24

Product code KOC

K003712Class IIModification to Male to Male Luer AdapterMolded Products, Inc. / cleared 2001-05-16

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)