Recall Z-2179-2012— Medical Specialties Distributors, Inc.

Name: FDA recall Z-2179-2012
Creator: U.S. Food and Drug Administration
Published: 2012-08-03

Class II · Terminated

Class II FDA medical device recall by Medical Specialties Distributors, Inc., initiated 2012-08-03, terminated 2015-01-23. It names one FDA 510(k) clearance: K090012. Product: Medstream 81" (206 cm) 20 Drop Standard bore Universal Administration Set with Y-Site, Sterile Manufactured for MSD (Medical Specialties Distributors LLC, Stoughton, MA. Product of China Product Number: MS721 Disposable Infusion set. Reason: Devices leaking at the Y-site.

Recalling firm: Medical Specialties Distributors, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-08-03
Terminated: 2015-01-23
Firm location: Stoughton, MA, 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 Standard bore Universal Administration Set with Y-Site, Sterile Manufactured for MSD (Medical Specialties Distributors LLC, Stoughton, MA. Product of China Product Number: MS721 Disposable Infusion set

Reason for recall

Devices leaking at the Y-site

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