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HomeMiltenyi Biotec B.V. & Co. KG › CryoMACS® Freezing Bag 250

CryoMACS® Freezing Bag 250

Miltenyi Biotec B.V. & Co. KG · Model 74401 · UDI-DI 04049934000287

KSR Prescription
10
510(k) clearances
617
Adverse events (8 deaths)
4
Recalls
32
Facilities

Description

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.

Recalls

DateFirmReason
2012-01-20DeRoyal Industries IncDevice's needle may become dislodged from the cup during shipment or during use.
2012-01-20DeRoyal Industries IncDevice's needle may become dislodged from the cup during shipment or during use.
2006-06-21Becton Dickinson & CompanyFirm received complaints indicating failure of the Non-Patient (NP) sleeve to function properly. This sleeve covers the cannula and prevents leakage during blood collection.
2005-12-01Becton Dickinson & CompanyCracked finger grip luer adapter components on the Push Button Blood Collection Set.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.