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

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  Reason
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  Affected products

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