Cryostore CS50SRecalls & reported problems
Origen Biomedical, Inc. · Cryostore 50 EVA Freezing Bag, 10 - 30 ml, standard tube set, case of 12, singly packed · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10816203021349), received between Oct 8, 2024 and Oct 8, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 8, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
A FREE-FLOATING ALUMINUM PARTCLE WAS FOUND IN THE FINAL PRODUCT FOR KYMRIAH (LENGTH OF THE PARTICLE WAS 422 MICROMETERS). THIS RESULTED IN THE TREATMENT NOT BEING PROVIDED TO THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 20402001 ↗
Other Container, Empty, For Collection & Processing Of Blood & Blood Components devices
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- CryoMACS® Freezing Bag 250 74401Miltenyi Biotec B.V. & Co. KG · Container, Empty, For Collection & Processing Of Blood & Blood Components20 reports
- CryoMACS® Freezing Bag 750 74403Miltenyi Biotec B.V. & Co. KG · Container, Empty, For Collection & Processing Of Blood & Blood Components14 reports
- CryoMACS® Freezing Bag 50 74400Miltenyi Biotec B.V. & Co. KG · Container, Empty, For Collection & Processing Of Blood & Blood Components6 reports
- CryoMACS® Freezing Bag 1000 74404Miltenyi Biotec B.V. & Co. KG · Container, Empty, For Collection & Processing Of Blood & Blood Components1 report
- DeRoyal 72-8000NSDeroyal Industries, Inc. · CONTAINER, EMPTY, FOR COLLECTION & PROCESSING OF BLOOD & BLOOD COMPONENTS1 report
- Transfer Pack 4R2014Fenwal, Inc. · Container, Empty, For Collection & Processing Of Blood & Blood Components1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.