RecallRadar

FDA Device recall Z-2543-2018

GIBCO CTS AIM V Serum-Free Media (SFM), Model Number 0870112BK. Tissue and cell culture medium

On 2018-08-01 the FDA classified a Class II recall of GIBCO CTS AIM V Serum-Free Media (SFM), Model Number 0870112BK. Tissue and cell culture medium by Life Technologies, citing 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 pa….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2543-2018
ClassificationClass II
Statusterminated
Initiated2018-05-10
Published2018-08-01
Last updated2026-09-13 11:54 UTC
CompanyLife Technologies
DistributionCA, CO, CT, FL, GA, MA, MD, PA, RI, UT, WA

Product

GIBCO CTS AIM V Serum-Free Media (SFM), Model Number 0870112BK. 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.

Identifiers

code_infoLot: 1923698

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2543-2018%22

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