The Recall Desk
HighFDA (Devices)·Z-2543-2018·Announced 2018-08-01

Life Technologies Recalls GIBCO CTS AIM V Serum-Free Media Due to Seal Defect

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.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (mold growth in sterile media) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Life Technologies, Corp. is recalling 141 units of GIBCO CTS AIM V Serum-Free Media (SFM), Model Number 0870112BK. The affected lot number is 1923698. This product is a tissue and cell culture medium.

The recall was initiated because the fill port tube seal integrity was compromised during the manufacture of the product lot. This defect may cause the media to leak out of the primary sterile packaging into the outer non-sterile dust cover packaging. Subsequently, mold may grow in the pooled, leaked media.

The product was distributed worldwide, including in the United States (CA, CO, CT, FL, GA, MA, MD, PA, RI, UT, and WA), Canada, France, Great Britain, Japan, Korea, the Netherlands, and Switzerland. Users should stop using the affected product and contact Life Technologies for further instructions.

The recalled product

Product
GIBCO CTS AIM V Serum-Free Media (SFM), Model Number 0870112BK. Tissue and cell culture medium.
Affected units
141

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot: 1923698

Distribution

Distributed in 11 states:

Part of a larger recall action

This product is one of 6 recalled by Life Technologies, Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →