CompoStop Flexible (2019-04-02)

Starting date:

April 2, 2019

Posting date:

April 9, 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-69552

Last updated: 2019-06-27

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  Reason
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  Affected products

Affected Products

CompoStop Flexible

Reason

Based on routine post-market surveillance Fresenius Kabi globally has identified an increased number of complaints for visible leakage of the platelet storage bag in CompoStop products. Such leakage predominantly occurs near the twist-off ports and has become apparent during processing of platelets in the storage bag. This type of defect has been identified by the user under routine handling conditions. The observed location of the leakage is in the area of the twist-off port weld in platelet storage bags.

Affected products