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Recall Observatory FDA recall evidence

Device 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

Z-2179-2012

August 03, 2012

Class II

Product summary

Firm
Medical Specialties Distributors, Inc.
Event
Event 62747
Status
Terminated
Classification
Class II
Quantity
472 cases (50/case)
Official record key
device-enforcement:Z-2179-2012

Official wording

Reason: Devices leaking at the Y-site

Code information: LOT NUMBER: 20111115

Distribution pattern: Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Devices leaking at the Y-site