Z-0969-2013Class II

Sterile Access & Return Line Set, 36" Length, Part # UM-872-36. Intended for use with medically prescribed...

Name: Z-0969-2013 Sterile Access & Return Line Set, 36" Length, Part # UM-872-36. Intended for use with medically prescribed...
Creator: Molded Products Inc
Published: 2012-06-19
License: https://open.fda.gov/license/

Molded Products Inc / initiated 2012-06-19 / Terminated / root cause: manufacturing process

FDA source

Molded Products Inc began a recall of Sterile Access & Return Line Set, 36" Length, Part # UM-872-36. Intended for use with medically prescribed hemodialysis blood tubing on 2012-06-19. FDA classified it as Class II and gives the reason as "The recalled product leaks at the connection site". 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-0969-2013
Classification: Class II
Status: Terminated
Initiated: 2012-06-19
Posted: 2013-03-18
Terminated: 2013-08-14
Recalling firm: Molded Products Inc
Product: Sterile Access & Return Line Set, 36" Length, Part # UM-872-36. Intended for use with medically prescribed hemodialysis blood tubing.
Product code: KOC Accessories, Blood Circuit, Hemodialysis
Reason for recall: The recalled product leaks at the connection site.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm's one customer was notified of the recall by phone call on 5/8/2012. The customer returned the affected product once the replacement product was received.
Quantity in commerce: 1200 sets
Distribution: Distributed to one customer in Michigan.
Product codes and lots: Lot numbers: 80106 and 80106b

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0969-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0969-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-27	2013-03-18

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)