Recall Z-0173-2019— Life Technologies, Corp.

Class II · Terminated

Class II FDA medical device recall by Life Technologies, Corp., initiated 2018-08-24, terminated 2020-04-29. FDA's recall record names no specific 510(k) clearance for this event. Product: Gibco Sodium Pyruvate (100 mM) SKU 11360070, for In-Vitro Diagnostic Use. Reason: Leaky bottles due to a defect in the bottle cap compromising the sterility of the product.

Recalling firm
Life Technologies, Corp.
Classification
Class II
Status
Terminated
Initiated
2018-08-24
Terminated
2020-04-29
Firm location
Grand Island, NY, United States

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.