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Recall Observatory FDA recall evidence

Device product

Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, Model Number 11965175. Tissue and cell culture medium.

Z-2545-2018

May 10, 2018

Class II

Product summary

Firm
Life Technologies, Corp.
Event
Event 80380
Status
Terminated
Classification
Class II
Quantity
91
Official record key
device-enforcement:Z-2545-2018

Official wording

Reason: It has been determined that the fill port tube seal integrity was compromised during the manufacture of the product lot. This may cause media to leak out of the primary sterile packaging into outer non-sterile dust cover packaging, and subsequently mold may grow in the pooled, leaked media.

Code information: Lot: 1945238

Distribution pattern: Worldwide distribution. US states: CA, CO, CT, FL, GA, MA, MD, PA, RI, UT, and WA., Canada, France, Great Britain, Japan, Korea, Netherlands, and Switzerland.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    It has been determined that the fill port tube seal integrity was compromised during the manufacture of the product lot. This may cause media to leak out of the primary sterile packaging into outer non-sterile dust cover packaging, and subsequently mold may grow in the pooled, leaked media.