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Recall Observatory FDA recall evidence

Device product

ALLERGAN UNIVERSAL FILL KIT, REF No. 7M2804. for tissue expander inflation.

Z-0134-2024

September 26, 2023

Class II

Product summary

Firm
B. Braun Medical, Inc.
Event
Event 93074
Status
Ongoing
Classification
Class II
Quantity
27.432 units
Official record key
device-enforcement:Z-0134-2024

Official wording

Reason: Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication. There is also the potential for life-threatening situations to occur requiring additional medical intervention.

Code information: UDI-DI: 4046964823749 Lot 0061745499, 0061745500, 0061745501, 0061792770

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada and Singapore.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication. There is also the potential for life-threatening situations to occur requiring additional medical intervention.