Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2543-2018 — GIBCO CTS AIM V Serum-Free Media (SFM), Model Number 0870112BK. Tissue and cell culture medium.

U.S. FDA — Device Enforcement · United States · 2018-05-10 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2543-2018
Date of alert
2018-05-10
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Life Technologies, Corp.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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