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Recall Observatory FDA recall evidence

Device product

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

Z-1277-2015

October 10, 2014

Class II

Product summary

Firm
US Infusion Inc dba Trucare Biomedix-USA
Event
Event 70143
Status
Terminated
Classification
Class II
Quantity
62,700 IV sets
Official record key
device-enforcement:Z-1277-2015

Official wording

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

Code information: Model # MS721, Lot # 20111115.

Distribution pattern: Distributed in the states of TX, IL, MA, OH, CA, and GA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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