Z-2542-2018 Class II Terminated

Recalled by Life Technologies, Corp. — Grand Island, NY

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
Updated as of 6/21/19: 6304 units

Product Description

Gibco CTS OpTmizer T Cell Expansion Serum Free Medium, bag format, Model Numbers A1048503 and A1022103. 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: 1921298, 1921302 Updated as of 6/14/19: 1902977 1902981 1904379 1904381 1912383 1915452 1921291 1925754 1921291 1921298 1921302 1925754