Container, Empty, For Collection & Processing Of Blood & Blood Components
Hematology · 21 CFR 864.9100
Recent MDR events
615 adverse event reports on file
- UMBILICUPJul 13, 2026MalfunctionDeroyal Industries, Inc.MW5190626
- IMUGARDNov 25, 2025MalfunctionTerumo Bct1722028-2025-00259
- IMUGARDOct 2, 2025MalfunctionTerumo Bct1722028-2025-00220
- IMUGARDApr 24, 2025MalfunctionTerumo Bct1722028-2025-00105
- IMUGARDApr 21, 2025MalfunctionTerumo Bct1722028-2025-00102
- IMUGARDApr 18, 2025MalfunctionTerumo Bct1722028-2025-00095
- IMUGARDApr 18, 2025MalfunctionTerumo Bct1722028-2025-00096
- IMUGARDApr 18, 2025MalfunctionTerumo Bct1722028-2025-00097
- IMUGARDApr 4, 2025MalfunctionTerumo Bct1722028-2025-00082
- IMUGARDFeb 13, 2025MalfunctionTerumo Bct1722028-2025-00034
Event type breakdown
Recalls
4 recall events for this product code
- DeRoyal Industries IncTerminatedApr 12, 2012
DeRoyal (R) Umbilicup, REF 72-8000, Rx Only, STERILE EO, Manufactured by DeRoyal, Powell, TN 37849
Device's needle may become dislodged from the cup during shipment or during use.
Z-1396-2012 · View FDA record ↗ - DeRoyal Industries IncTerminatedApr 12, 2012
DeRoyal (R) Umbilicup, REF 72-8000NS, Rx Only, Manufactured by DeRoyal, Powell, TN 37849
Device's needle may become dislodged from the cup during shipment or during use.
Z-1398-2012 · View FDA record ↗ - Becton Dickinson & CompanyTerminatedSep 9, 2006
BD Direct Draw Adapters, Catalog Number 364896.
Firm received complaints indicating failure of the Non-Patient (NP) sleeve to function properly. This sleeve covers the cannula and prevents leakage during blood collection.
Z-1463-06 · View FDA record ↗ - Becton Dickinson & CompanyTerminatedJan 11, 2006
BD Vacutainer Push Button Blood Collection Set with Pre-Attached holder.
Cracked finger grip luer adapter components on the Push Button Blood Collection Set.
Z-0372-06 · View FDA record ↗
Registered firms
122 firms currently registered for this product code
Haemotronic De Mexico S De Rl
REYNOSA Tamaulipas, MX
Sterigenics Us, Llc
Lewis Center, OH, US
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Terumo Corp.
SHIBUYA-KU, TOKYO, JP
Origen Biomedical, Inc.
Austin, TX, US
Sterigenics U.s., Llc
Corona, CA, US
Fenwal International, Inc.
HAINA San Cristobal, DO
Sterigenics Us Llc
Fort Worth, TX, US
Haemonetics Corporation
Boston, MA, US
Sterigenics Us Llc
Gurnee, IL, US
Fenwal, Inc.
LAKE ZURICH, IL, US
Global Life Sciences Solutions Usa Llc
Marlborough, MA, US
Gvs Tm, Inc.
Covina, CA, US
Terumo Corporation Fujinomiya Factory
FUJINOMIYA-SHI Shizuoka, JP
Sterigenics U.s., Llc
Atlanta, GA, US
Terumo Bct, Inc..
Lakewood, CO, US
Sterigenics Us Llc
West Memphis, AR, US
510(k) clearances
16 clearances for this product code
- Tyco HealthcareDec 8, 2003
K032827 · KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501
- DeroyalJun 13, 2002
K020753 · DEROYAL SURGICAL, UMBILICUP
- Alpha Therapeutic Corp.Sep 23, 1981
K810897 · ALPHA PLASTIC PLASMA BOTTLE
- Delmed, Inc.Sep 23, 1981
K810500 · BLOOD FREEZING BAG
- Terumo America, Inc.Sep 9, 1981
K811523 · PLASMA FLEX
- Haemonetics Corp.Jul 1, 1981
K811449 · HAEMONETICS 1000ML COMPONENT BAG
- Haemonetics Corp.May 8, 1981
K810711 · HAEMONETICS 600 ML. COMPONENT BAG
- Haemonetics Corp.Mar 31, 1981
K810313 · HAEMONETICS 1400 ML THERAPEUTIC BAG