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CryoMACS® Freezing Bag 1000 74404Recalls & reported problems

Miltenyi Biotec B.V. & Co. KG · The CryoMACS® Freezing Bags are single use only, sterile (by irradiation), containers intended for a single cycle of freezing, storage (down to -196°C), and subsequent thawing (at 37°C) of hematopoietic progenitor cells. The CryoMACS® Freezing Bags are comprised of a freezing bag (with access ports) as the primary containment for the hematopoietic progenitor cells and an overwrap bag as secondary containment. They have an integrated tubing set (Filling Assembly) containing an injection port and male and female luer lock assemblies which provide flexibility to use a variety of disposable transfer sets, syringes or Sterile Connecting Device (SCD®) for aseptic processing. Additionally, the CryoMACS® Freezing Bags have a built-in label pocket which allows the insertion of written information such as patient identification and product specifications for hematopoietic progenitor cells, volume and processing methods used. As part of the bag assembly, two spike ports are available which allow access to the bag contents for therapeutic use of the product (via attachment of a sterile transfusion assembly). Intended Use: The CryoMACS® Freezing Bag are intended for a single cycle of freezing, storage (down to -196°C), and subsequent thawing (at 37°C) of hematopoietic progenitor cells. · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04049934000317), received between Nov 12, 2020 and Nov 12, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Crack” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Crack1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 12, 2020Crack; Crack

    THE CRYOMACS BAG WAS USED FOR STORING AUTOLOGOUS BLOOD PRODUCT FROM A PATIENT. THE USER FOUND A LEAKAGE WHEN WIPING THE BAG AFTER THAWING. THE AFFECTED BLOOD SAMPLE WAS DISCARDED AND NOT USED FOR THE PATIENT. THE PATIENT TREATMENT WAS DONE WITH BACKUP MATERIAL. CRACKS WERE FOUND NEAR THE EVA TUBE. ACCORDING TO THE QUESTIONNAIRES FILLED IN BY THE USER, THE FOLLOWING INVESTIGATION AND STATEMENTS COULD BE MADE: THE EVENT WAS OBSERVED DURING THAWING. THE CUSTOMER DID USE A METAL CASSETTE FOR FREEZING BUT NOT FOR STORAGE AS IT IS RECOMMENDED. A CONTROLLED RATE FREEZER WAS NOT USED. THE FREEZING BAG WAS STORED WITH AN OVERWRAP BAG FOR CELL RESCUE. THE OVERWRAP BAG WAS EVACUATED. THE CELLS WERE STORED IN THE LIQUID PHASE OF LN2 AND THE BAG WAS NOT STORED IN THE VAPOR PHASE PRIOR TO THE REMOVAL FROM THE STORAGE TANK AS IT IS RECOMMENDED. THE FILLING VOLUME WAS 350 ML (125 ML - 270 ML ARE RECOMMENDED). THE LOCATION OF THE CRACK NEAR THE CONNECTION TO THE EVA TUBE IS MARKED ON THE PICTURE. THE INVESTIGATION OF THE PICTURES SHOWS, THAT THE ISSUE IS LIKELY CAUSED BY PHYSICAL STRESS (E.G. MECHANICAL IMPACT). ACCORDING TO THE QUESTIONNAIRE, THERE ARE SEVERAL DEVIATIONS FROM THE RECOMMENDED FREEZ

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 10829263 ↗

Other Container, Empty, For Collection & Processing Of Blood & Blood Components devices

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Sources and updates

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