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Recall Observatory FDA recall evidence

Device product

Nimbus Administration Set, REF HS-004, UDI # 00817170020031 Product Usage: Administer fluids/medication from a container to a patient through a needle or a catheter.

Z-2055-2019

May 28, 2019

Class II

Product summary

Firm
InfuTronix LLC
Event
Event 82997
Status
Terminated
Classification
Class II
Quantity
10,800 units
Official record key
device-enforcement:Z-2055-2019

Official wording

Reason: Potential for tube leakage

Code information: 1) Lot # 1805002, Exp Date 06/10/2021, 2) Lot # 1712005, Exp Date 12/19/2020, 3) Lot # 1710012, Exp Date 10/22/2020, 4) Lot # 1901003, Exp Date 01/07/2022

Distribution pattern: US distribution in the state of MA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for tube leakage