Health product recall

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

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

CompoStop Flexible

Lot or serial number

41MC12GA00
41ME01GA00
41MH01GA00
41MI30GA00
41MK06GA00
41MK31GA00
41ML08GA00
41ML22GA00
85NA13CA00

Model or catalog number

PD51600

Companies
Manufacturer

Fresenius AG

Else-Kröner-Str. 1

Bad Homburg

61352

GERMANY