GJEClass II
Tray, Blood Collection
Clinical Chemistry · 21 CFR 862.1675
MDR events113All time
Recalls1All time
Registered firms4Currently listed
510(k) clearances7All time
Recent MDR events
113 adverse event reports on file
- ANGEL WING 23G BCS W/ LUER ADPTRJul 28, 2014MalfunctionCovidien1282497-2014-00044
- ANG WNG 23G BCS W/LUER ATR X50Jul 18, 2014MalfunctionCovidien1282497-2014-00043
- ANGEL WING 23G BCS W/LUER ADPTRJan 15, 2014MalfunctionCovidien1282497-2014-00005
- MONOJETDec 13, 2013MalfunctionCovidien3537310
- MONOJECTNov 13, 2013MalfunctionCovidien3560680
- ANGEL WING 23G BCS W/LUER ADPTRApr 4, 2013MalfunctionCovidien1282497-2013-00008
- ANGEL WNG 25GX3 / 4X12IN TUBINGNov 5, 2012MalfunctionCovidien1282497-2012-00024
- ANG WING 23GA BCS W/BC HLDRSep 20, 2010MalfunctionCovidien1282497-2010-00020
- ANG WING 23GA BCS W/BC HLDRSep 20, 2010MalfunctionCovidien1282497-2010-00019
- AW TRANSFER SET FOR BACT ALERTJul 28, 2010MalfunctionCovidien1282497-2010-00014
Event type breakdown
Malfunction77
Other16
Injury11
Unspecified8
Death1
Recalls
1 recall events for this product code
Registered firms
4 firms currently registered for this product code
510(k) clearances
7 clearances for this product code
- Customed, Inc.Sep 27, 1996
K962596 · CUSTOMED BLOOD EXTRACTION KIT
- J.J. Skinner, Inc.Apr 11, 1994
K925468 · JJ SKINNER CAREKITS(TM) BLOOD COLLECTION KIT
- Bd Becton Dickinson Vacutainer Systems PreanalyticMar 30, 1978
K780303 · AUTO ISO-FILTER COLLECTION TUBE CAP
- Bd Becton Dickinson Vacutainer Systems PreanalyticAug 22, 1977
K771489 · RTERIAL BLOOD SAMPLING KIT
- Bd Becton Dickinson Vacutainer Systems PreanalyticAug 3, 1977
K771370 · ICROTAINEO BRAND TUBE
- Bio/Data Corp.Jan 10, 1977
K761177 · SODIUM CITRATE
- Concord Laboratories, Inc.Jul 16, 1976
K760086 · TRAY, BLOOD SAMPLING (PULSATOR II)