CAKClass 2
Microfilter, Blood Transfusion
FDA adverse event reports and recall history for microfilter, blood transfusion (product code CAK), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 1,646
- Deaths
- 7
- Injuries
- 110
- Malfunctions
- 1,397
Reports per year
611
10413
3714
5815
9716
13117
5818
33419
18020
1821
11022
6923
1924
6225
4626
Source: FDA adverse event reports by year received, 2011–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2026-01-22Open, ClassifiedProcess control
SQ40S Blood Transfusion Filter
Due to products being released for distribution prior to completion of the required quality control release process the sterility assurance cannot be confirmed.
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