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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.
June 14, 2017Medical DevicesFDA
Arrow International Inc recalls MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device, Integral Hemostasis Valve, Sharps Saf
Hazard: Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
June 7, 2017Medical DevicesFDA
Arrow International Inc recalls Arrow(R) VPS(R) Access Kit for use with 4 and 5 Fr. Peripherally Inserted Central Venous Catheters
Hazard: Arrow International is notifying each customer who received the affected that product that the kits do not contain important information regarding the 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing.
May 3, 2017Medical DevicesFDA
Arrow International Inc recalls Pressure Injectable Arrowg+ard Blue Plus Multi-Lumen Central Venous Catheterization Kit. Permits venous access to centr
Hazard: Arrow International is recalling due to possible voids in the catheter hub, which could lead to an interlumen crossover.
April 12, 2017Medical DevicesFDA
Arrow International Inc recalls The CG+ Arrow PIC Catheters permit venous access to the central circulation through a peripheral vein.
Hazard: Arrow International, Inc. notified its customers who received the affected Antimicrobial/Antithrombogenic PICC Kits, that the kits were being recalled due to a labeling error. The lidstock on some of the kits reads CDC-45541-HPK1A, while the banner card on the side of the kit reads CDC-45052-HPK1A. Other kits may list CDC-45052-HPK1A on the lidstock and CDC-45541-HPK1A on the banner card. The affected lot numbers are 23F16C0851, 23F16A0727, and 23F16C0844.
March 1, 2017Medical DevicesFDA
Arrow International Inc recalls Vascular catheter introduction kit The PICC is indicated for short or long term peripheral access to the central Venous
Hazard: There have been complaints for peel away sheaths flaring
November 9, 2016Medical DevicesFDA
Arrow International Inc recalls HANDS-OFF Infusion Port Thermodilution Catheter consists of the Arrow IPTD thermodilution catheter enclosed in a contami
Hazard: Labeling inconsistency
October 12, 2016Medical DevicesFDA
Arrow International Inc recalls Walrus Arterial Embolectomy Catheter The arterial embolectomy catheter is intended for use in removing arterial embol
Hazard: Arrow is recalling due to incorrect labeling of products.
September 21, 2016Medical DevicesFDA
Arrow International Inc recalls Catheter, Intravascular, Therapeutic, Short-Term Less than 30 days The Arrow CVC is indicated to provide short-term (
Hazard: Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.
September 21, 2016Medical DevicesFDA
Arrow International Inc recalls Catheter, Percutaneous The Arrow Single-Lumen Catheter permits venous access to the central circulation.
Hazard: Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.
September 21, 2016Medical DevicesFDA
Arrow International Inc recalls Cather, Ultrasound, Intravascular The VPS Stylet and Console are indicated for guidance and tip positioning for centr
Hazard: Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.
September 21, 2016Medical DevicesFDA
Arrow International Inc recalls Catheter, Intravascular, Therapeutic, Long Term Greater than 30 days. An access kit only, contains no base components
Hazard: Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.
September 14, 2016Medical DevicesFDA
Arrow International Inc recalls Radial Artery Catheterization Kit with Sharps Safety Features Permits access to the peripheral arterial circulation. Th
Hazard: Shipping carton labeling error.
September 14, 2016Medical DevicesFDA
Arrow International Inc recalls Arterial Line Catheterization Kit with Sharps Safety Features Permits access to the peripheral arterial circulation or
Hazard: Shipping carton labeling error.
July 20, 2016Medical DevicesFDA
Arrow International Inc recalls Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D0
Hazard: Labeling error. Some shipping cartons labeled as ASK-04018-VUH contained ASK-04020-VUH kits; and some shipping cartons labeled as ASK-04020-VUH contained ASK-04018-VUH kits.
July 20, 2016Medical DevicesFDA
Arrow International Inc recalls Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D0
Hazard: Labeling error. Some shipping cartons labeled as ASK-04018-VUH contained ASK-04020-VUH kits; and some shipping cartons labeled as ASK-04020-VUH contained ASK-04018-VUH kits.
July 13, 2016Medical DevicesFDA
Arrow International Inc recalls ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER. Product Usage: Indicated to
Hazard: Arrow is recalling these products due to the possibility that although the kit is labeled as containing a 20 cm catheter, a 16 cm catheter may be packaged in the kit.
March 16, 2016Medical DevicesFDA
Arrow International Inc recalls Super Arrow-Flex Percutaneous Sheath Introducer Sets REF CL-07035 or CL-07635 or CL-07735 or CL-07835 Super Arrow-Fl
Hazard: Arrow has issued a recall for these products due to potential packaging damage. The sterility of the products cannot be guaranteed. If non-sterile product is used there is a potential for infection to occur.
November 11, 2015Medical DevicesFDA
Arrow International Inc recalls ARROW PICC Kit featuring Chlorag+ard Technology Midline Catheterization Kit ARROW Advantage5 Pressure Injectable PICC
Hazard: 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. Although the issue does not pose a significant risk to the patient, it may cause a delay of treatment when placing the catheter.
October 21, 2015Medical DevicesFDA
Arrow International Inc recalls 4FR Single Lumen Pressure Injectable PICC; intravascular therapeutic catheter, for long-term use greater than 30 days.
Hazard: Labeling inaccuracy in the Instructions for Use (IFU) and Patient Card. The IFU and Patient Card with these products state the PICC can withstand up to ten (10) pressure injections, however, the PICC has only been tested to withstand five (5) pressure injections.
October 7, 2015Medical DevicesFDA
Arrow International Inc recalls Arrow Kits with Medtronic Covidien 0.9% Sodium Chloride Flush Syringes
Hazard: Manufacturer of 0.9% Sodium Chloride Flush Syringes recalled due to compromised sterility of the outer barrel, Arrow purchased recalled items that were packaged with certain products.
September 9, 2015Medical DevicesFDA
Arrow International Inc recalls Arrow International, Inc. PICC Kits and VPS Access Kits with Touhy Borst Component Catheter, Intravascular, Therapeutic,
Hazard: saline leakage from unsecured connections between the Touhy Borst adaptor and the hub of the catheter. No injuries reported.
September 2, 2015Medical DevicesFDA
Arrow International Inc recalls PICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeutic, ultrasound Product Usage: catheter,
Hazard: the catheter peel-away component hub tabs may prematurely detach. One injury reported.
March 18, 2015Medical DevicesFDA
Arrow International Inc recalls Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Model: IAB-05840-LWS
Hazard: Potential for a leak between the catheter and the bifurcate which would allow helium to escape to the atmosphere.
March 11, 2015Medical DevicesFDA
Arrow International Inc recalls ARROW FiberOptix Intra-Aortic Balloon Catheter Kit, 40 cc 7.5 Fr Product Code: IAB-05840-LWS The Arrow IAB is utilized
Hazard: Outer package product label incorrectly identifies the product as FiberOptix Flex IAB 7.5Fr rather than the correct FiberOptix IAB 8Fr
February 18, 2015Medical DevicesFDA
Arrow International Inc recalls ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit. The Multiple-Lumen Catheter permits venous access to the cen
Hazard: Foreign material found within the kits. The foreign material, white or black particles and/or thread, is visible and can beidentified by the user.
February 18, 2015Medical DevicesFDA
Arrow International Inc recalls ARROW Epidural Needle Component (product number AN-05501). Epidural needles permit access to the epidural space and are
Hazard: The product labeling does not specify the 5 year shelf life of the product.
February 4, 2015Medical DevicesFDA
Arrow International Inc recalls Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial Catheterization Kit (NA) with Biopatch Dre
Hazard: Certain product codes and lot numbers of Kits with Biopatch Dressing were packaged with the incorrect size Biopatch Dressing. No risk to patients is anticipated.
January 28, 2015Medical DevicesFDA
Arrow International Inc recalls The Arrow Edge Hemodialysis Catheterization Set Long-Term Access and NextStep Antegrade Hemodialysis Catheterization Set
Hazard: The tunneling sheath packaged within the kits can crack during placement. If the tunneling sheath cracks, it can cause a delay in treatment for the time it takes to retrieve a replacement kit.
January 28, 2015Medical DevicesFDA
Arrow International Inc recalls 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: Pr
Hazard: the Instructions for Use (IFU) were inadvertently removed from the kit.
December 17, 2014Medical DevicesFDA
Arrow International Inc recalls Arrow Nerve Block Component, Product Code: AB-18040-N: Permits placement of catheters next to nerves and nerve plexuses
Hazard: Arrow is recalling certain lots of the Continuous Nerve Block Component, Product Code: AB-18040-N, due to a labeling inconsistency. The product lidstock incorrectly identifies the needle in the finished good as 17Ga rather than the correct 18Ga. The product included in the package is the correct 18Ga size. No injuries or illnesses have been reported.