Data Foundry

Medical device recalls 2013

Sterile Access & Return Line Set — Class II medical device recall Z-0969-2013

Terminated recall by Molded Products Inc, reported 2013-03-27, distributed in MI. The recalled product leaks at the connection site.

Recall numberZ-0969-2013
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmMolded Products Inc, Harlan, IA, United States
Recall initiated2012-06-19
Classified2013-03-18
Reported by FDA2013-03-27
Terminated2013-08-14
DistributedMI
Quantity1,200 sets
Reason classespackaging
Lot numbers80106, 80106B
Model numbersUM-872-36

Product

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

Reason for recall

The recalled product leaks at the connection site.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0969-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.