Recall Z-2547-2018— Life Technologies, Corp.
Class II · Terminated
Class II FDA medical device recall by Life Technologies, Corp., initiated 2018-05-10, terminated 2020-05-05. FDA's recall record names no specific 510(k) clearance for this event. Product: Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, pyruvate, Model Number 11995123. Tissue and cell culture medium.. 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..
- Recalling firm
- Life Technologies, Corp.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-05-10
- Terminated
- 2020-05-05
- Firm location
- Grand Island, NY, United States
Product description
Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, pyruvate, Model Number 11995123. 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.