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ARROW INTERNATIONAL Recalls

525 recalls on record · June 27, 2012 to June 24, 2026 · Medical Devices

Recalls by year

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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.

March 21, 2018Medical DevicesFDA
Arrow International Inc recalls Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features Product Usage
Hazard: Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
February 28, 2018Medical DevicesFDA
Arrow International Inc recalls ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet
Hazard: The kit may contain an incorrect catheter component. Kits that should contain a 40cm catheter may contain a 55cm catheter.
February 28, 2018Medical DevicesFDA
Arrow International Inc recalls ARROWg+ard Blue Two Lumen Hemodialysis Catheterization Kit for High Volume Infusions; Product Codes: AK-22142-CDC, AK-22
Hazard: These finished good kits may contain the incorrect Springwire Guide (SWG).
February 28, 2018Medical DevicesFDA
Arrow International Inc recalls Central Venous Catheterization Kit with Blue FlexTip Catheter; Product code: AK-04301; Exp. Dates Feb 2018 - Nov 2018
Hazard: These finished good kits may contain the incorrect Springwire Guide (SWG).
February 28, 2018Medical DevicesFDA
Arrow International Inc recalls ARROWg+ard Blue Plus Multi Lumen CVC (Central venous catheter); Product Code: AK-45703-ACDC; Exp. Dates Feb 2018 - Nov 2
Hazard: These finished good kits may contain the incorrect Springwire Guide (SWG).
February 28, 2018Medical DevicesFDA
Arrow International Inc recalls AGB+ Multi Lumen Central Venous Catheterization Kit; Product Codes: CDC-42703-XP1A and CDC-47702-XP1A; Exp. Dates Feb 20
Hazard: These finished good kits may contain the incorrect Springwire Guide (SWG).
February 28, 2018Medical DevicesFDA
Arrow International Inc recalls Arrow Multi Lumen CVC Kit (Central venous catheter); Product Code: CDC-15703-1A; Exp. Dates Feb 2018 - Nov 2018
Hazard: These finished good kits may contain the incorrect Springwire Guide (SWG).
February 28, 2018Medical DevicesFDA
Arrow International Inc recalls Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen Central Venous Catheterization Kit; Product code: ASK-45703-PHF2;
Hazard: These finished good kits may contain the incorrect Springwire Guide (SWG).
February 28, 2018Medical DevicesFDA
Arrow International Inc recalls Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter, Sharps Safety Features, and Maximal Barrier P
Hazard: These finished good kits may contain the incorrect Springwire Guide (SWG).
February 28, 2018Medical DevicesFDA
Arrow International Inc recalls Pressure Injectable Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter and Sharps Safety Feature
Hazard: These finished good kits may contain the incorrect Springwire Guide (SWG).
February 28, 2018Medical DevicesFDA
Arrow International Inc recalls Multi Lumen Central Venous Catheterization Kit; Product Code: ASK-12703-HH2; Exp. Dates Feb 2018 - Nov 2018
Hazard: These finished good kits may contain the incorrect Springwire Guide (SWG).
February 28, 2018Medical DevicesFDA
Arrow International Inc recalls Pressure Injectable ARROWg+ard Blue PLUS MultiLumen Central Venous Catheterization Kit; Product Codes: ASK-45703-PNHS;
Hazard: These finished good kits may contain the incorrect Springwire Guide (SWG).
February 28, 2018Medical DevicesFDA
Arrow International Inc recalls Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter and Sharps Safety Features; Product Code: ASK
Hazard: These finished good kits may contain the incorrect Springwire Guide (SWG).
February 28, 2018Medical DevicesFDA
Arrow International Inc recalls Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen Central Venous Catheterization Kit; Product Code: ASK 42703 PUHC; E
Hazard: These finished good kits may contain the incorrect Springwire Guide (SWG).
February 21, 2018Medical DevicesFDA
Arrow International Inc recalls ArrowADVANTAGE 5 Pressure Injectable Peripherally Inserted Central Catheter (PICC). Product Codes: PR-35041-HPHNM and CD
Hazard: Finished good kits may contain incorrect components. Kits that should contain a 5 FR 2 lumen catheter may contain a 4 FR single lumen catheter and kits that should contain a 4 FR single lumen catheter may contain a 5 FR 2 lumen catheter. This may cause a delay in treatment while a replacement catheter is obtained.
February 21, 2018Medical DevicesFDA
Arrow International Inc recalls ARROW PICC powered by ARROW VPS Stylet, Product Codes: CDC-35052-VPS and CDC-35041-VPS. Peripherally Inserted Central C
Hazard: Finished good kits may contain incorrect components. Kits that should contain a 5 FR 2 lumen catheter may contain a 4 FR single lumen catheter and kits that should contain a 4 FR single lumen catheter may contain a 5 FR 2 lumen catheter. This may cause a delay in treatment while a replacement catheter is obtained.
February 21, 2018Medical DevicesFDA
Arrow International Inc recalls Radial Artery Catheterization Set, 1) NA-04550-1A & 2) NA-04550-X1A, device permits access to the peripheral arterial ci
Hazard: Needle supplier indicated the presence of loose polypropylene foreign matter above release specification.
December 6, 2017Medical DevicesFDA
Arrow International Inc recalls ArrowADVANTAGE5" Pressure Injectable Peripherally Inserted Central Catheter (PICC) The Pressure Injectable PICC is indi
Hazard: There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths.
December 6, 2017Medical DevicesFDA
Arrow International Inc recalls ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet The Pressure Injectable PICC is indicated for short or long term peripheral a
Hazard: There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths.
December 6, 2017Medical DevicesFDA
Arrow International Inc recalls ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet The Pressure Injectable PICC is indicated for short or long term peripheral a
Hazard: There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths.
December 6, 2017Medical DevicesFDA
Arrow International Inc recalls Arrow(R) VPS(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter The intended use of the VPS
Hazard: There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths.
July 19, 2017Medical DevicesFDA
Arrow International Inc recalls Arrow Glide Thru Peel-Away Sheath/Dilator Introducer
Hazard: Arrow is recalling additional lots that were identified as part of an active recall. Arrow is recalling the affected product due to the possibility that the catheter peel-away component hub tabs may prematurely detach when the practitioner begins to peel apart the sheath body from the catheter.
July 19, 2017Medical DevicesFDA
Arrow International Inc recalls Arrow EVOLUTION Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology
Hazard: Arrow is recalling additional lots that were identified as part of an active recall. Arrow is recalling the affected product due to the possibility that the catheter peel-away component hub tabs may prematurely detach when the practitioner begins to peel apart the sheath body from the catheter.
June 21, 2017Medical DevicesFDA
Arrow International Inc recalls Arrow Pressure Injectable PICC Kit Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days The Arrow Pres
Hazard: The Arrow Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling.
June 21, 2017Medical DevicesFDA
Arrow International Inc recalls ARROWg+ard Blue CVC Kit The ARROWg+ard Blue CVCs are intended to permit venous access to the central circulation
Hazard: The Arrow CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: -multiple infusions of fluids, medications, or chemotherapy -infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values -frequent blood sampling or blood/blood components infusions -infusion of incompatible medications -central venous pressure monitoring lack of usable peripheral IV sites -replacement of multiple peripheral sites for IV access
June 21, 2017Medical DevicesFDA
Arrow International Inc recalls Arrow Multi-Lumen CVC Kit The Arrow Two-Lumen Central Venous Access device permits venous access and catheter introduct
Hazard: The Arrow CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: -multiple infusions of fluids, medications, or chemotherapy -infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values -frequent blood sampling or blood/blood components infusions -infusion of incompatible medications -central venous pressure monitoring lack of usable peripheral IV sites -replacement of multiple peripheral sites for IV access
June 21, 2017Medical DevicesFDA
Arrow International Inc recalls Arrow MAC Two-Lumen Central Venous Access Kit Introducer Catheter The Arrow Two-Lumen Central Venous Access device per
Hazard: Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
June 21, 2017Medical DevicesFDA
Arrow International Inc recalls 1) ARROWg+ard Blue You-Blend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions The large-bore two-lu
Hazard: Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
June 21, 2017Medical DevicesFDA
Arrow International Inc recalls 1) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit 2) ARROWg+ard Blue PSI Kit 3) ARROWg+ard Blue MAC Two-Lumen
Hazard: Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
June 21, 2017Medical DevicesFDA
Arrow International Inc recalls Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety
Hazard: Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.