BSAClass III
Warmer, Blood, Electromagnetic Radiation
Hematology · 21 CFR 864.9205
MDR events6All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances0All time
Recent MDR events
6 adverse event reports on file
- WARMER BLOOD ELECTROMAGNETFeb 20, 2022Malfunction3012307300-2022-03713
- LEVEL 1 FAST FLOW FLUID WARMERFeb 29, 2016InjurySmiths Medical Asd, Inc.5466188
- MEDI-TEMP IIJan 9, 2006Malfunction1313850-2005-00003
- BAXTERApr 6, 1999MalfunctionAllegiance Healthcare Corp.219623
- SYSTEM 250/FLUID WARMERJul 21, 1994DeathLevel One Technologies Inc.8282
- BLOOD WARMERFeb 4, 1994MalfunctionFenwal Corp7739
Event type breakdown
Malfunction4
Death1
Injury1
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.