Z-2544-2018 Class II Terminated
FDA device recall Z-2544-2018 was initiated by Life Technologies, Corp. on May 10, 2018 and is designated Class II. 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 no… The recall status is terminated (terminated May 5, 2020). Affected quantity: 45.
Recall Details
- Product Type
- Devices
- Report Date
- August 1, 2018
- Initiation Date
- May 10, 2018
- Termination Date
- May 5, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 45
Product Description
Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, pyruvate, Model Number 11995115. 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 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.
Code Information
Lot: 1932659