Manufacturer

ARROW INTERNATIONAL Inc.

478 recalls in our database name ARROW INTERNATIONAL Inc. as the manufacturing or recalling firm.

What the numbers show

Total: 478
Critical: 1
Severe: 136
Most recent: 2024-10-02

Of the 478 recalls from ARROW INTERNATIONAL Inc. we have scored against our rubric, 1 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 136 (28%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

451–475 of 478

ModerateFDA (Devices)·Z-0207-2016·2015-11-11
Arrow International Recalls PICC Kits Due to Hub Tab Detachment
Arrow International Inc is recalling 12,157 units of various PICC and midline catheter kits because the peel-away component hub tabs may prematurely detach during use.
Product
ARROW PICC Kit featuring Chlorag+ard Technology Midline Catheterization Kit ARROW Advantage5 Pressure Injectable PICC Kit Arrow¿ Pressure Injectable Arrow¿ PICC powered by Arrow¿ VPS¿ Stylet ARROW Pressure Injectable JACC with Chlorag+ard Technology For short-term or long-te
Category
Medical Device
Distribution
36 states
ModerateFDA (Devices)·Z-0127-2016·2015-10-21
Arrow International Recalls PICC Catheters Due to Labeling Inaccuracy
Arrow International Inc is recalling 4FR Single Lumen Pressure Injectable PICC catheters because the instructions state they withstand 10 pressure injections, but they are only tested for 5.
Product
4FR Single Lumen Pressure Injectable PICC; intravascular therapeutic catheter, for long-term use greater than 30 days.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2825-2015·2015-10-07
Arrow Kits with Medtronic Syringes Recalled for Compromised Sterility
Arrow International Inc. is recalling Arrow Kits containing Medtronic Covidien 0.9% Sodium Chloride Flush Syringes due to compromised sterility of the outer barrel.
Product
Arrow Kits with Medtronic Covidien 0.9% Sodium Chloride Flush Syringes
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2489-2015·2015-09-09
Arrow International Recalls PICC and VPS Access Kits with Touhy Borst Catheters
Arrow International is recalling PICC and VPS Access Kits with Touhy Borst catheters due to saline leakage from unsecured connections. No injuries have been reported.
Product
Arrow International, Inc. PICC Kits and VPS Access Kits with Touhy Borst Component Catheter, Intravascular, Therapeutic, Ultrasound, Long Term Greater than 30 Days
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2462-2015·2015-09-02
Arrow International Recalls PICC Kits with Potential Peel-Away Sheath Defect
Arrow International is recalling 52,109 PICC kits because the peel-away sheath hub tabs may prematurely detach. One injury has been reported.
Product
PICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeutic, ultrasound Product Usage: catheter, intravascular, therapeutic, ultrasound
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1259-2015·2015-03-18
Arrow Intra-Aortic Balloon Catheter Kit Recalled for Potential Helium Leak
Arrow International Inc is recalling 166 units of Intra-Aortic Balloon Catheter Kits due to a potential leak that allows helium to escape.
Product
Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Model: IAB-05840-LWS
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1233-2015·2015-03-11
Arrow FiberOptix Intra-Aortic Balloon Catheter Kit Recalled for Labeling Error
Arrow International Inc. is recalling 165 units of FiberOptix Intra-Aortic Balloon Catheter Kits because the outer package label incorrectly identifies the product size.
Product
ARROW FiberOptix Intra-Aortic Balloon Catheter Kit, 40 cc 7.5 Fr Product Code: IAB-05840-LWS The Arrow IAB is utilized for intra-aortic balloon counter-pulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood suppl
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1082-2015·2015-02-18
Arrow International Recalls Two-Lumen CVC Kits Due to Foreign Material
Arrow International Inc is recalling 1,195 ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kits because visible foreign material was found inside the kits.
Product
ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit. The Multiple-Lumen Catheter permits venous access to the central circulation by way of the femoral jugular, or subclavian veins.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1080-2015·2015-02-18
Arrow Epidural Needle Component Recalled for Missing Shelf Life Labeling
Arrow International Inc. is recalling 63,022 units of ARROW Epidural Needle Components because the product labeling does not specify the 5-year shelf life.
Product
ARROW Epidural Needle Component (product number AN-05501). Epidural needles permit access to the epidural space and are used as a conduit for epidural catheter placement.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1030-2015·2015-02-04
Arrow Medical Kits Recalled for Incorrect Biopatch Dressing Size
Arrow International Inc. is recalling specific medical kits because they were packaged with the incorrect size Biopatch Dressing. No risk to patients is anticipated.
Product
Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial Catheterization Kit (NA) with Biopatch Dressing
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1007-2015·2015-01-28
Arrow Hemodialysis Catheterization Sets Recalled for Tunneling Sheath Cracking
Arrow International is recalling specific hemodialysis catheterization sets because the tunneling sheath can crack during placement, potentially delaying treatment.
Product
The Arrow Edge Hemodialysis Catheterization Set Long-Term Access and NextStep Antegrade Hemodialysis Catheterization Set, Long-Term Access, part numbers: AC-15192-SFX, AC-15232-SFX, AC-15272-SFX, AC-15312-SFX, AC-15422-SFX, CS-15192-SFX, CS-15192-SFXM, CS-15232-SFX, CS-15242-I, C
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-1005-2015·2015-01-28
Arrow International Recalls Multi-Lumen CVC Kits Due to Missing Instructions
Arrow International Inc is recalling 420 Multi-Lumen PI CVC Kits and PSI Kits because the Instructions for Use were inadvertently removed from the packaging.
Product
Multi-Lumen PI CVC Kit and PSI Kit: 3-L 7 FR X 8 product code: ASK-45703-POSU lot #23F13L0166, exp. 31-Jul-2015: Product Usage: Multi-Lumen PI CVC Kit: An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is i
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0573-2015·2014-12-17
Arrow Recalls Nerve Block Components Due to Labeling Inconsistency
Arrow International Inc is recalling specific lots of Continuous Nerve Block Components because the packaging incorrectly identifies the needle gauge. No injuries or illnesses have been reported.
Product
Arrow Nerve Block Component, Product Code: AB-18040-N: Permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0114-2015·2014-10-29
Arrow International Recalls Epidural Anesthesia Kits with Incorrect Syringe Components
Arrow International is recalling 300 units of an epidural anesthesia kit because the kit contains a Luer-Lock syringe instead of the labeled Luer-Slip syringe.
Product
ASK-05501-AFH1, Lot Number 23F13K0969 Anesthesia Conduction Catheter, Epidural Anesthesia Kit
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0066-2015·2014-10-22
Arrow Select Kits Recalled Due to Potential Sterility Compromise
Arrow International is recalling Select Kits and Maximal Barrier Precautions Kits containing BD Posiflush syringes because open seals may compromise sterility.
Product
Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medical Posiflush 10mL Saline Flush Syringe.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0076-2015·2014-10-22
Arrow International Recalls Central Venous Catheter Kits Due to Labeling Error
Arrow International is recalling 65 Multi-Lumen Central Venous Catheterization Kits because the outer shipping box displays an incorrect expiration date. The kits inside are correctly labeled and pose no risk to patients.
Product
Multi-Lumen Central Venous Catheterization Kit
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-1713-2014·2014-06-11
Arrow Percutaneous Sheath Introducer Kits Recalled for Dilator Tip Damage
Arrow International Inc is recalling specific Percutaneous Sheath Introducer Kits due to dilator tip damage that could cause vessel injury.
Product
Arrow¿ Percutaneous Sheath Introducer Kits The Percutaneous sheath introducer products permit venous or arterial access and device introduction to the central circulation.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1633-2014·2014-05-28
Arrowgard Blue Central Venous Catheter Recalled for Labeling Error
Arrow International Inc. is recalling Arrowgard Blue and Blue Plus catheters because the packaging incorrectly lists an echogenic needle, which may not be present.
Product
Arrowgard Blue and Arrowgard Blue Plus Pressure Injectable Central Venous Catheter, a multiple-lumen catheter that permits venous access to central circulation. Catalog number ASK-45703-PHF.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1507-2014·2014-04-30
Arrow Recalls Antimicrobial Central Venous Catheters Due to Labeling Error
Arrow International is recalling 170 units of Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheters because the lidstock incorrectly lists the catheter length as 16CM instead of 20CM.
Product
Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter, catalogue number AK-45854-CDC.
Category
Medical Device
Distribution
12 states
ModerateFDA (Devices)·Z-1494-2014·2014-04-30
Arrow Pressure Injectable PICC Catheter Recall Due to Incorrect Length
Arrow International Inc. is recalling 789 units of Arrow Pressure Injectable PICC catheters because they contain a 40cm catheter instead of the required 50cm catheter.
Product
Arrow Pressure Injectable PICC Powered by Arrow VPS Stylet Catalogue number CDC-35052-VPS, peripherally inserted central catheter.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0546-2014·2013-12-25
Arrow International Recalls Nerve Block Catheter Kits Due to Labeling Error
Arrow International is recalling 121 Continuous Peripheral Nerve Block Catheter Kits because the packaging incorrectly describes the stimulator cable connector.
Product
Continuous Peripheral Nerve Block Catheter Kit and Set Continuous Peripheral Nerve Block Catheter Kit and Set permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0468-2014·2013-12-18
Arrow Transradial Artery Access Products Recalled for Occluded Needles
Arrow International Inc is recalling Transradial Artery Access products because introducer needles may be occluded, posing a risk of delayed treatment or adverse events.
Product
Arrow Transradial Artery Access products Arrow Transradial Artery Access products are used for percutaneous introduction of devices into the radial artery for diagnostic and therapeutic purposes.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1965-2013·2013-08-21
Arrow International Recalls Two-Lumen CVC Kits Due to Labeling Error
Arrow International is recalling 156 Two-Lumen CVC Kits because a portion of the packaging incorrectly identifies the catheter as 3-Lumen.
Product
Arrow International, Inc. Two-Lumen CVC Kit with Blue Flex Tip Catheter. The multiple lumen catheter permits venous access to the central circulation of patients.
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-1065-2013·2013-04-17
Arrow International Recalls FiberOptix Intra-Aortic Balloon Catheter Kits
Arrow International is recalling 637 units of FiberOptix Intra-Aortic Balloon Catheter Kits due to a potential internal leak at the fill port.
Product
Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 40 cc; Product Number: IAB-05840-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation therapy.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1064-2013·2013-04-17
Arrow International Recalls FiberOptix Intra-Aortic Balloon Catheter Kits
Arrow International is recalling 188 units of FiberOptix Intra-Aortic Balloon Catheter Kits due to a potential internal leak at the fill port.
Product
Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 30 cc; Product Number: IAB-05830-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation therapy.
Category
Medical Device
Distribution
0 states