ExactaMix EVA Container (2019-09-19)

Starting date:

September 19, 2019

Posting date:

November 5, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type I

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-71531

Last updated: 2019-11-05

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  Reason
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  Affected products

Affected Products

ExactaMix EVA Container

Reason

Baxter Corporation has previously issued a voluntary product recall for certain lot numbers of the ExactaMix empty EVA bags due to the potential ability to leak once used for compounding. Baxter is expanding this recall to include additional lot numbers.

There were 1612 complaints (5374 units) identified that are potentially related to this issue.  166 out of the 1612 complaints were of canadian origin.  Please note that these 1612 complaints are for the 1622 lot numbers that are within scope of this issue, however, Canada only distributed 430 lots out of the affected 1622 lots.

There have been no reports of serious injury associated with this issue.

Affected products