FDA (Devices) recall action 80380
The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Life Technologies is recalling 70 units of Gibco DMEM cell culture medium because compromised fill port seals may allow media to leak and grow mold.
Life Technologies is recalling 91 units of Gibco DMEM tissue culture medium because compromised fill port seals may allow media to leak and grow mold.
Life Technologies is recalling Gibco DMEM tissue culture medium because compromised seal integrity may allow media to leak and grow mold.
Life Technologies is recalling Lot 1930752 of Gibco RPMI 1640 Medium because compromised fill port tube seals may allow media to leak and mold to grow.
Life Technologies is recalling Gibco CTS OpTmizer T Cell Expansion Serum Free Medium due to compromised fill port tube seals that may allow mold growth.
Life Technologies is recalling 141 units of GIBCO CTS AIM V Serum-Free Media because compromised seal integrity may allow media to leak and grow mold.