Recall Z-1277-2015— US Infusion Inc dba Trucare Biomedix-USA

Name: FDA recall Z-1277-2015
Creator: U.S. Food and Drug Administration
Published: 2014-10-10

Class II · Terminated

Class II FDA medical device recall by US Infusion Inc dba Trucare Biomedix-USA, initiated 2014-10-10, terminated 2015-06-23. It names one FDA 510(k) clearance: K090012. Product: Medstream 81" (206 cm) 20 drop Universal Administration Sets. Disposable IV infusion set with 3 year expiration date.. Reason: Several complaints regarding the IV sets leaking at the Y site..

Recalling firm: US Infusion Inc dba Trucare Biomedix-USA
Classification: Class II
Status: Terminated
Initiated: 2014-10-10
Terminated: 2015-06-23
Firm location: South Miami, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K090012 — DISPOSABLE INFUSION SETShan Dong Wei Gao Group Medical Polymer Products·cleared 2009-06-11

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

Medstream 81" (206 cm) 20 drop Universal Administration Sets. Disposable IV infusion set with 3 year expiration date.

Reason for recall

Several complaints regarding the IV sets leaking at the Y site.

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