Z-2179-2012 Class II Terminated

Recalled by Medical Specialties Distributors, Inc. — Stoughton, MA

FDA device recall Z-2179-2012 was initiated by Medical Specialties Distributors, Inc. on August 3, 2012 and is designated Class II. Reason for recall: Devices leaking at the Y-site The recall status is terminated (terminated January 23, 2015). Affected quantity: 472 cases (50/case).

Recall Details

Product Type
Devices
Report Date
August 15, 2012
Initiation Date
August 3, 2012
Termination Date
January 23, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
472 cases (50/case)

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

Distribution Pattern

Nationwide Distribution

Code Information

LOT NUMBER: 20111115