Device product
Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, Model Number 11965175. Tissue and cell culture medium.
Z-2545-2018
Product summary
- 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
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.