Recall Z-2543-2018— Life Technologies, Corp.

Name: FDA recall Z-2543-2018
Creator: U.S. Food and Drug Administration
Published: 2018-05-10

Class II · Terminated

Class II FDA medical device recall by Life Technologies, Corp., initiated 2018-05-10, terminated 2020-05-05. It names one FDA 510(k) clearance: K022086. 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..

Recalling firm: Life Technologies, Corp.
Classification: Class II
Status: Terminated
Initiated: 2018-05-10
Terminated: 2020-05-05
Firm location: Grand Island, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K022086 — AIM-V (R) MEDIUM, MODEL 087-0112Invitrogen Corporation·cleared 2002-12-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.