Recall Z-1679-2017— Molded Products Inc

Name: FDA recall Z-1679-2017
Creator: U.S. Food and Drug Administration
Published: 2015-01-20

Class II · Terminated

Class II FDA medical device recall by Molded Products Inc, initiated 2015-01-20, terminated 2017-03-30. It names one FDA 510(k) clearance: K003712. Product: Non-Sterile Double DIN to DIN "Y" Connector, Product Usage: Extension for connecting hemodialysis blood tubing to the hemodialyzer.. Reason: A customer relayed a complaint of a leaking dialysis tubing connector..

Recalling firm: Molded Products Inc
Classification: Class II
Status: Terminated
Initiated: 2015-01-20
Terminated: 2017-03-30
Firm location: Harlan, IA, United States

510(k) clearances named in this recall

1 on FDA's record

K003712 — MODIFICATION TO MALE TO MALE LUER ADAPTERMolded Products, Inc.·cleared 2001-05-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Non-Sterile Double DIN to DIN "Y" Connector, Product Usage: Extension for connecting hemodialysis blood tubing to the hemodialyzer.

Reason for recall

A customer relayed a complaint of a leaking dialysis tubing connector.

Data sourced from openFDA. This site is unofficial and independent of the FDA.