Health product recall

OpTmizer CTS T-Cell Expansion SFM (2019-05-15)

Starting date:
May 15, 2019
Posting date:
May 31, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-70071

Last updated: 2019-05-31

Affected Products

OpTmizer CTS T-Cell Expansion SFM

Reason

Defective machine which was used to bond the fill tube and bag. This caused improper sealing which led to media leaking from the fill tube/bag seal only when the bag was placed under stress in a specific packaging configuration. This issue was first identified on june 11th, 2018.

Affected products

OpTmizer CTS T-Cell Expansion SFM

Lot or serial number

1925754

Model or catalog number

A1022103

Companies
Manufacturer
LIFE TECHNOLOGIES CORPORATION ALSO TRADING AS: INVITROGEN
3175 Staley Road
Grand Island
14072
New York
UNITED STATES