FDA recall Z-2545-2018

Life Technologies, Corp. · Class II · device

Product

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

Reason for recall

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.

Distribution

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.

Key facts

Status
Terminated
Initiation date
2018-05-10
Report date
2018-08-01
Termination date
2020-05-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Grand Island, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2545-2018