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Recall Observatory FDA recall evidence

Device product

Gibco Sodium Pyruvate (100 mM) SKU 11360070, for In-Vitro Diagnostic Use

Z-0173-2019

August 24, 2018

Class II

Product summary

Firm
Life Technologies, Corp.
Event
Event 81052
Status
Terminated
Classification
Class II
Quantity
41 units
Official record key
device-enforcement:Z-0173-2019

Official wording

Reason: Leaky bottles due to a defect in the bottle cap compromising the sterility of the product

Code information: Lot# 1967697 Exp. Date 30-Jun-2019. (UDI 10190302001823)

Distribution pattern: Nationwide: Foreign: Argentina Australia Canada China Great Britain Hong Kong India Japan Mexico Netherlands New Zealand Singapore South Korea Taiwan

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Leaky bottles due to a defect in the bottle cap compromising the sterility of the product