Blood Transfusion Kit
General Hospital · 21 CFR 880.5440
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Recent MDR events
11 adverse event reports on file
- FRESH WHOLE BLOOD TRANSFUSION SETJun 4, 2021MalfunctionCombat Medical Systems Llc3008258694-2021-00011
- UNKNOWNFeb 2, 2021MalfunctionCombat Medical Systems Llc3008258694-2021-00005
- UNKNOWNFeb 2, 2021MalfunctionCombat Medical Systems Llc3008258694-2021-00006
- UNKNOWNFeb 2, 2021MalfunctionCombat Medical Systems Llc3008258694-2021-00008
- UNKNOWNFeb 2, 2021MalfunctionCombat Medical Systems Llc3008258694-2021-00007
- UNKNOWNFeb 2, 2021MalfunctionCombat Medical Systems Llc3008258694-2021-00009
- UNKNOWNFeb 2, 2021MalfunctionCombat Medical Systems Llc3008258694-2021-00010
- FRESH WHOLE BLOOD TRANSFUSION SETJan 13, 2021MalfunctionCombat Medical Systems Llc3008258694-2021-00001
- VALKYRIE FRESH WHOLE BLOOD SETJan 13, 2021MalfunctionCombat Medical Systems Llc3008258694-2021-00004
- VALKYRIE LOW TITER TYPE O WHOLE BLOOD KITJan 13, 2021MalfunctionCombat Medical Systems Llc3008258694-2021-00002
Event type breakdown
Most-reported manufacturers
Recalls
5 recall events for this product code
- Combat Medical Systems, LLCTerminatedFeb 19, 2021
Valkyrie LTOWB Collection (P/N 80-820, NSN 6515016862423). Blood collection convenience kit.
There is the potential of a bent or disconnected needle in one of the components of the convenience kits.
Z-1110-2021 · View FDA record ↗ - Combat Medical Systems, LLCTerminatedFeb 19, 2021
Valkyrie LTOWB Administration (P/N 80-821 NSN 6515016862401). Blood convenience kit.
There is the potential of a bent or disconnected needle in one of the components of the convenience kits.
Z-1111-2021 · View FDA record ↗ - Combat Medical Systems, LLCTerminatedFeb 19, 2021
Low Titer Type O FWB Transfusion Set (P/N 80-875 NSN 651501684994). Blood convenience kit.
There is the potential of a bent or disconnected needle in one of the components of the convenience kits.
Z-1112-2021 · View FDA record ↗ - Combat Medical Systems, LLCTerminatedFeb 19, 2021
Fresh Whole Blood Transfusion Set (P/N 80-801 NSN 6515016574750) . Blood convenience kit.
There is the potential of a bent or disconnected needle in one of the components of the convenience kits.
Z-1113-2021 · View FDA record ↗ - Combat Medical Systems, LLCTerminatedFeb 19, 2021
Fresh Whole Blood Donor Set (P/N 80-801-D NSN 6515016640306) . Blood convenience kit.
There is the potential of a bent or disconnected needle in one of the components of the convenience kits.
Z-1114-2021 · View FDA record ↗
Registered firms
13 firms currently registered for this product code
Safeguard Us Operating, Llc
Huntersville, NC, US
Cardinal Health 200, Llc
El Paso, TX, US
Bound Tree Medical, Llc
Grand Prairie, TX, US
Sterigenics Us Llc
Grand Prairie, TX, US
Sterigenics U.s., Llc
Charlotte, NC, US
Isomedix Operations Inc
El Paso, TX, US
Synchronis Medical Llc
Romulus, MI, US
Huzhou Junda Industry Co., Ltd.
Anji Zhejiang, CN
Convertors De Mexico S. De R.l. De C.v
CD.JUAREZ Chihuahua, MX
Isomedix Operations Inc
EL PASO, TX, US
Cardinal Health 200, Llc
Waukegan, IL, US
Chinook Medical Gear, Inc.
Tulsa, OK, US
North American Rescue, Llc.
Greer, SC, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.