FDA Device

Gibco CTS OpTmizer T Cell Expansion Serum Free Medium, bag format, Model Numbers A1048503 and A1022103. Tissue and cell culture medium.

Hazard

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.

What You Should Do

Remedy

Urgent Medical Device Recall Notification letters dated 6/28/18 were distributed to customers to notify them of the recall of GIBCO CTS AIM V Serum-Free Media (SFM); Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, pyruvate; Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose; and Gibco RPMI 1640 Medium. The letters instructed customers to do the following: For the above mentioned lots of product, please complete an inspection of the seal integrity of your inventory. There should not be visual evidence of media within the space between the media bag itself and the dust cover. If you are using product that was manufactured between the dates noted above and you have confirmed media between the media bag and dust cover, we ask that you dispose of these bags per local and state requirements and complete the attached Customer Response Form. As noted above, for bags that do not have any visible media beyond the seal, we have confirmed through sterility testing that these units meet sterility specifications and are acceptable for use. Please inform all affected users within your organization of this notification. If you have used this product in manufacturing, you must notify impacted customers and impacted facilities of this notice and our concern for the potential of fill tube seal integrity loss. Please complete the following Customer Response Sheet if you have product that was manufactured between September 2017 and December 2017 and you have confirmed visual evidence of media between the media bag and dust cover. We will work with you to ensure that you receive credit for the discarded material. North American customers: Please complete the following Customer Response Sheet if you have confirmed visual evidence of at the bag-port or media between the media bag and dust cover in your material. Email a scanned copy of the response sheet along with this letter to customer.relations@thermofisher.com. If you have any questions, please ca

Products

Gibco CTS OpTmizer T Cell Expansion Serum Free Medium, bag format, Model Numbers A1048503 and A1022103. Tissue and cell culture medium.
Brand
Life Technologies, Corp.
UPC
Lot: 1921298, 1921302  Updated as of 6/14/19: 1902977 1902981 1904379 1904381 1912383 1915452 1921291 1925754 1921291 1921298 1921302 1925754

Units Affected

Updated as of 6/21/19: 6304 units