Recall Z-0969-2013— Molded Products Inc

Name: FDA recall Z-0969-2013
Creator: U.S. Food and Drug Administration
Published: 2012-06-19

Class II · Terminated

Class II FDA medical device recall by Molded Products Inc, initiated 2012-06-19, terminated 2013-08-14. It names one FDA 510(k) clearance: K003712. Product: Sterile Access & Return Line Set, 36" Length, Part # UM-872-36. Intended for use with medically prescribed hemodialysis blood tubing.. Reason: The recalled product leaks at the connection site..

Recalling firm: Molded Products Inc
Classification: Class II
Status: Terminated
Initiated: 2012-06-19
Terminated: 2013-08-14
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

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.

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