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ARROW INTERNATIONAL Inc.

353 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
EPIDURAL CATHETERIZATION KIT, Product Code MTO-05500-SU recall (Z-1208-2020)Arrow International Inc2020-01-24
FlexTip Plus Epidural Catheterization Set, Product Code MTO-05500-TK recall (Z-1209-2020)Arrow International Inc2020-01-24
EPIDURAL CATHETERIZATION KIT, Product Code MTO-09903-KU recall (Z-1210-2020)Arrow International Inc2020-01-24
FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code NYU-05500-1 recall (Z-1211-2020)Arrow International Inc2020-01-24
FlexTip Plus Epidural Catheterization Kit, Product Code TI-05501-ME recall (Z-1212-2020)Arrow International Inc2020-01-24
Epidural Catheterization Kit with FlexTip Plus Catheter, Product Code TI-05520-EPI recall (Z-1213-2020)Arrow International Inc2020-01-24
EPIDURAL CATHETERIZATION KIT, Product Code UR-05501 recall (Z-1214-2020)Arrow International Inc2020-01-24
EPIDURAL CATHETERIZATION KIT, Product Code UR-05501-EXP recall (Z-1215-2020)Arrow International Inc2020-01-24
EPIDURAL CATHETERIZATION KIT, Product Code UR-05501-FR1 recall (Z-1216-2020)Arrow International Inc2020-01-24
FlexTip Plus Epidural Catheterization Kit, Product Code YC-02220 recall (Z-1217-2020)Arrow International Inc2020-01-24
EPIDURAL CATHETERIZATION KIT, Product Code BJC-05400-BEN recall (Z-1218-2020)Arrow International Inc2020-01-24
ARROWg+ard Blue PLUS catheter, Catalog Number: ASK-45854-NG Product Usage: The ARROWg+ard recall (Z-1152-2018)Arrow International Inc2018-03-21
ARROW ENDURANCE" Extended Dwell Peripheral Catheter System, Catalog Numbers: EDC-00820 & E recall (Z-1194-2018)Arrow International Inc2018-03-14
Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety recall (Z-1158-2018)Arrow International Inc2018-03-05
Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip Cath recall (Z-1159-2018)Arrow International Inc2018-03-05
Percutaneous Sheath Introducer Kit with ARROWg+ard Blue Sheath, Integral Hemostasis Valve/ recall (Z-1160-2018)Arrow International Inc2018-03-05
Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip(R), recall (Z-1161-2018)Arrow International Inc2018-03-05
Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip, ARR recall (Z-1162-2018)Arrow International Inc2018-03-05
Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip, ARR recall (Z-1163-2018)Arrow International Inc2018-03-05
Pressure Injectable Two- Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROW recall (Z-1164-2018)Arrow International Inc2018-03-05
Pressure Injectable Multi- Lumen CVC Kit recall (Z-1165-2018)Arrow International Inc2018-03-05
ARROWg+ard Blue PLUS Pressure Injectable Multi-Lumen CVC Kit. Intended to permit venous ac recall (Z-1166-2018)Arrow International Inc2018-03-05
Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen Central Venous Catheterization Kit; P recall (Z-0647-2018)Arrow International Inc2018-02-20
Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter and Sharps Safet recall (Z-0648-2018)Arrow International Inc2018-02-20
Pressure Injectable ARROWg+ard Blue PLUS MultiLumen Central Venous Catheterization Kit; Pr recall (Z-0649-2018)Arrow International Inc2018-02-20
Multi Lumen Central Venous Catheterization Kit; Product Code: ASK-12703-HH2; Exp. Dates Fe recall (Z-0650-2018)Arrow International Inc2018-02-20
Pressure Injectable Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Cathe recall (Z-0651-2018)Arrow International Inc2018-02-20
Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter, Sharps Safety F recall (Z-0652-2018)Arrow International Inc2018-02-20
Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen Central Venous Catheterization Kit; P recall (Z-0653-2018)Arrow International Inc2018-02-20
Arrow Multi Lumen CVC Kit (Central venous catheter); Product Code: CDC-15703-1A; Exp. Date recall (Z-0654-2018)Arrow International Inc2018-02-20
AGB+ Multi Lumen Central Venous Catheterization Kit; Product Codes: CDC-42703-XP1A and CDC recall (Z-0655-2018)Arrow International Inc2018-02-20
ARROWg+ard Blue Plus Multi Lumen CVC (Central venous catheter); Product Code: AK-45703-ACD recall (Z-0656-2018)Arrow International Inc2018-02-20
Central Venous Catheterization Kit with Blue FlexTip Catheter; Product code: AK-04301; Exp recall (Z-0657-2018)Arrow International Inc2018-02-20
ARROWg+ard Blue Two Lumen Hemodialysis Catheterization Kit for High Volume Infusions; Prod recall (Z-0658-2018)Arrow International Inc2018-02-20
Arrow EVOLUTION Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogen recall (Z-2698-2017)Arrow International Inc2017-06-27
Arrow Glide Thru Peel-Away Sheath/Dilator Introducer recall (Z-2699-2017)Arrow International Inc2017-06-27
Pressure Injectable Arrowg+ard Blue Plus Multi-Lumen Central Venous Catheterization Kit. P recall (Z-1879-2017)Arrow International Inc2017-04-10
The CG+ Arrow PIC Catheters permit venous access to the central circulation through a peri recall (Z-1705-2017)Arrow International Inc2017-03-08
Arterial Line Catheterization Kit with Sharps Safety Features Permits access to the periph recall (Z-2740-2016)Arrow International Inc2016-09-07
Radial Artery Catheterization Kit with Sharps Safety Features Permits access to the periph recall (Z-2741-2016)Arrow International Inc2016-09-07
Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product recall (Z-2201-2016)Arrow International Inc2016-07-12
Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product recall (Z-2202-2016)Arrow International Inc2016-07-12
ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER. Pr recall (Z-2136-2016)Arrow International Inc2016-07-06
ARROW PICC Kit featuring Chlorag+ard Technology Midline Catheterization Kit ARROW Advantag recall (Z-0207-2016)Arrow International Inc2015-11-04
4FR Single Lumen Pressure Injectable PICC; intravascular therapeutic catheter, for long-te recall (Z-0127-2016)Arrow International Inc2015-10-15
Arrow Kits with Medtronic Covidien 0.9% Sodium Chloride Flush Syringes recall (Z-2825-2015)Arrow International Inc2015-09-30
Arrow International, Inc. PICC Kits and VPS Access Kits with Touhy Borst Component Cathete recall (Z-2489-2015)Arrow International Inc2015-08-31
PICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeutic, ultrasoun recall (Z-2462-2015)Arrow International Inc2015-08-25
Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Model: IAB-05840-LWS recall (Z-1259-2015)Arrow International Inc2015-03-10
ARROW FiberOptix Intra-Aortic Balloon Catheter Kit, 40 cc 7.5 Fr Product Code: IAB-05840-L recall (Z-1233-2015)Arrow International Inc2015-03-02
ARROW Epidural Needle Component (product number AN-05501). Epidural needles permit access recall (Z-1080-2015)Arrow International Inc2015-02-10
ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit. The Multiple-Lumen Catheter pe recall (Z-1082-2015)Arrow International Inc2015-02-10
Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial Catheterizati recall (Z-1030-2015)Arrow International Inc2015-01-29
Multi-Lumen PI CVC Kit and PSI Kit: 3-L 7 FR X 8 product code: ASK-45703-POSU lot #23F13L0 recall (Z-1005-2015)Arrow International Inc2015-01-22
The Arrow Edge Hemodialysis Catheterization Set Long-Term Access and NextStep Antegrade He recall (Z-1007-2015)Arrow International Inc2015-01-22
Arrow Nerve Block Component, Product Code: AB-18040-N: Permits placement of catheters next recall (Z-0573-2015)Arrow International Inc2014-12-12
ASK-05501-AFH1, Lot Number 23F13K0969 Anesthesia Conduction Catheter, Epidural Anesthesia recall (Z-0114-2015)Arrow International Inc2014-10-22
Multi-Lumen Central Venous Catheterization Kit recall (Z-0076-2015)Arrow International Inc2014-10-16
Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medical Posiflu recall (Z-0066-2015)Arrow International Inc2014-10-14
Arrow Percutaneous Sheath Introducer Kits The Percutaneous sheath introducer products perm recall (Z-1713-2014)Arrow International Inc2014-06-04
Arrowgard Blue and Arrowgard Blue Plus Pressure Injectable Central Venous Catheter, a mult recall (Z-1633-2014)Arrow International Inc2014-05-19
Arrow Pressure Injectable PICC Powered by Arrow VPS Stylet Catalogue number CDC-35052-VPS, recall (Z-1494-2014)Arrow International Inc2014-04-24
Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter, catalogue number AK recall (Z-1507-2014)Arrow International Inc2014-04-24
Continuous Peripheral Nerve Block Catheter Kit and Set Continuous Peripheral Nerve Block C recall (Z-0546-2014)Arrow International Inc2013-12-19
Arrow Transradial Artery Access products Arrow Transradial Artery Access products are used recall (Z-0468-2014)Arrow International Inc2013-12-09
Arrow International, Inc. Two-Lumen CVC Kit with Blue Flex Tip Catheter. The multiple lume recall (Z-1965-2013)Arrow International Inc2013-08-14
Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 30 cc; Product recall (Z-1064-2013)Arrow International Inc2013-04-06
Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 40 cc; Product recall (Z-1065-2013)Arrow International Inc2013-04-06
Arrow/Teleflex Medical Berman Angiographic Balloon Catheter and Reverse Berman Angiographi recall (Z-1057-2013)Arrow International Inc2013-04-04
Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip(R) ARROWgard Blue(R) recall (Z-1830-2012)Arrow International Inc2012-06-26
Arrow International, Inc. 7FR 3-Lumen Arrowg+ard Blue Plus(R) Pressure Injectable Central recall (Z-1823-2012)Arrow International Inc2012-06-19
Arrow International StimuCath(R) Continuous Nerve Block Kit, ASK-19608-SFH, Lot # MF012703 recall (Z-0309-2012)Arrow International Inc2011-11-30
Arrow NextStep Antegrade Chronic Hemodialysis Catheter. Product is used for attaining long recall (Z-2883-2011)Arrow International Inc2011-07-30
Arrow ASK-20608-CMC StimuCath Continuous Nerve Block Kit. Arrow International, Inc. Permit recall (Z-2894-2011)Arrow International Inc2011-07-29
SINGLE SHOT EPIDURAL ANESTHESIA KIT/Product SKU's (Codes) AK-03000, AM-03000, BH-03000, DH recall (Z-1343-2011)Arrow International Inc2011-02-17
INTERNAL JUGULAR PUNCTURE KIT with Blue FlexTip(R) Catheter/Product SKU (Code) AK-04050 In recall (Z-1344-2011)Arrow International Inc2011-02-17
PEDIATRIC JUGULAR PUNCTURE KIT/Product SKU (Code) AK-04150-E Pediatric jugular puncture ki recall (Z-1345-2011)Arrow International Inc2011-02-17
ARTERIAL LINE KIT/Product SKU (Code) AK-04510 Arterial line kit recall (Z-1346-2011)Arrow International Inc2011-02-17
VESSEL CATHETERIZATION KIT/Product SKU's (Codes) AK-04550, AK-4550-A and ASK-04550-TG. Ves recall (Z-1347-2011)Arrow International Inc2011-02-17
CENTRAL VENOUS CATHETERIZATION KIT/Product SKU's (Codes) AK-04650-E and AK-04660. Central recall (Z-1348-2011)Arrow International Inc2011-02-17
JUGULAR PUNCTURE KIT/Product SKU (Code) AK-04800. Jugular puncture kit recall (Z-1349-2011)Arrow International Inc2011-02-17
EPIDURAL CATHETERIZATION KIT with FlexTip Plus(R) EPIDURAL CATHETER -- Product SKU (Code) recall (Z-1350-2011)Arrow International Inc2011-02-17
ACCESS TRAY/Product SKU's (Codes) ASK-03000-CHUQ, ASK-03000-CHUQ1, ASK-04001-GFH, ASK-0400 recall (Z-1351-2011)Arrow International Inc2011-02-17
EPIDURAL ANESTHESIA KIT/Product SKU's (Codes) ASK-03001-KC, ASK-03001-KC1 and HH-03000. Ep recall (Z-1352-2011)Arrow International Inc2011-02-17
PREP TRAY/Product SKU (Code) ASK-04001-SLE. Prep tray for epidural anesthesia kit recall (Z-1353-2011)Arrow International Inc2011-02-17
NERVE BLOCK PREP TRAY/Product SKU (Code) ASK-04001-VCU. Nerve block prep tray for epidural recall (Z-1354-2011)Arrow International Inc2011-02-17
ARTERIAL CATHETERIZATION KIT/Product SKU (Code) ASK-04100-AMC. Arterial catheterization ki recall (Z-1355-2011)Arrow International Inc2011-02-17
RADIAL ARTERY CATHETERIZATION KIT/Product SKU (Code) ASK-04120-VBH. Cardiovascular artery recall (Z-1356-2011)Arrow International Inc2011-02-17
QuickFlash(R) RADIAL ARTERY/ARTERIAL LINE CATHETERIZATION KIT/Product SKU (Code) ASK-04500 recall (Z-1357-2011)Arrow International Inc2011-02-17
ARTERIAL CATHETERIZATION KIT/Product SKU's (Codes) CC-04100, FS-04510, NS-04100 and PW-041 recall (Z-1358-2011)Arrow International Inc2011-02-17
RADIAL ARTERY CATHETERIZATION KIT with SHARPS SAFETY FEATURES/Product SKU (Code) HF-04020- recall (Z-1359-2011)Arrow International Inc2011-02-17
ARTERIAL ACCESS TRAY/Product SKU (Code) MMC-04001-1. Arterial access tray for radial arter recall (Z-1360-2011)Arrow International Inc2011-02-17
EPIDURAL CATHETERIZATION KIT with FlexTip Plus(R) CATHETER/Product SKU (Code) NH-05501. An recall (Z-1361-2011)Arrow International Inc2011-02-17
Arrow WH-02220 - Epidural Catheterization Kit with FlexTip Plus(R) Catheter Intended use: recall (Z-1012-2011)Arrow International Inc2011-02-01
Super Arrow-Flex(R) PSI Set Intended for use in the hospital catheterization laboratory fo recall (Z-0936-2011)Arrow International Inc2011-01-21
Arrow-Howes (TM) Multi Lumen Central Venous Catheterization Set with Blue FlexTip(R) Cathe recall (Z-0898-2011)Arrow International Inc2011-01-12
MAC Two-Lumen Central Venous Access kit with Integral Hemostasis Valve for use with 7 - 8 recall (Z-2488-2010)Arrow International Inc2010-09-25
Two-Lumen Central Venous Catheterization kit with Blue FlexTip Catheter (Sharps Safety Fea recall (Z-2489-2010)Arrow International Inc2010-09-25
Multi-Lumen Central Venous Catheterization kit with Blue FlexTip Catheter (Sharps Safety F recall (Z-2490-2010)Arrow International Inc2010-09-25
Multi-Lumen Pressure Injectable Central Venous Catheterization kit with Blue FlexTip Cathe recall (Z-2491-2010)Arrow International Inc2010-09-25
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Every clearance here is in the API, with alerts when new ones post.