Home / Recalls / Life Technologies, Corp. / Z-2543-2018

Z-2543-2018 Class II Terminated

Recalled by Life Technologies, Corp. — Grand Island, NY

Recall Details

Product Type
Devices
Report Date
August 1, 2018
Initiation Date
May 10, 2018
Termination Date
May 5, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
141

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.

Distribution Pattern

Worldwide distribution. US states: CA, CO, CT, FL, GA, MA, MD, PA, RI, UT, and WA., Canada, France, Great Britain, Japan, Korea, Netherlands, and Switzerland.

Code Information

Lot: 1923698

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  • Z-0172-2019 Class II — Gibco DPBS, calcium, magnesium, for In-Vitro Diagnostic Use SKU 14040141 (August 24, 2018)
  • Z-0174-2019 Class II — Gibco GlutaMAX Supplement, for In-Vitro Diagnostic Use SKU 35050061 (August 24, 2018)
  • Z-2546-2018 Class II — Gibco RPMI 1640 Medium, Model Number 61870150. Tissue and cell culture medium. (May 10, 2018)
  • Z-2545-2018 Class II — Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, Model Number 119651 (May 10, 2018)
  • Z-2542-2018 Class II — Gibco CTS OpTmizer T Cell Expansion Serum Free Medium, bag format, Model Numbers (May 10, 2018)
  • Z-2544-2018 Class II — Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, pyruvate, Model Num (May 10, 2018)
  • Z-2547-2018 Class II — Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, pyruvate, Model Num (May 10, 2018)