The Recall Desk

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.

426–450 of 478

  • HighFDA (Devices)·Z-2298-2017·2017-06-14

    Arrow QuickFlash Radial Artery Catheterization Kit Recalled for Needlestick Risk

    Arrow International is recalling QuickFlash Radial Artery Catheterization Kits due to reports of safety cover disengagement and needlestick injuries associated with packaged BD Eclipse Needles.

    Product
    QuickFlash Radial Artery/Arterial Line Catheterization Kit The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2306-2017·2017-06-14

    Arrow International Recalls Two-Lumen Hemodialysis Catheterization Kits

    Arrow International Inc is recalling specific lots of two-lumen hemodialysis catheterization kits due to a Class II medical device recall.

    Product
    Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions for High Volume Infusions The Arrow(r) CVC is indicated to provide short-term ( < 30 days) central venous access for treatment of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2255-2017·2017-06-14

    Arrow International Recalls Central Venous Access Kits Due to Needlestick Risk

    Arrow International is recalling specific Central Venous Access Kits because the packaged BD Eclipse Needle may disengage, posing a needlestick injury risk.

    Product
    ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2308-2017·2017-06-14

    Arrow International Recalls Hemodialysis Catheterization Kits

    Arrow International Inc. is recalling ARROWg+ard Blue You-Bend Two-Lumen Hemodialysis Catheterization Kits due to a Class II recall.

    Product
    ARROWg+ard Blue You-Bend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions The Arrow(r) 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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2280-2017·2017-06-14

    Arrow International Recalls Pressure Injectable PICC Kits Due to Needlestick Risk

    Arrow International is recalling Pressure Injectable PICC Kits because packaged BD Eclipse Needles may disengage, posing a needlestick injury risk.

    Product
    Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2258-2017·2017-06-14

    Arrow International Recalls Central Venous Catheter Kits Due to Needlestick Risk

    Arrow International is recalling 43,394 central venous catheter kits because the packaged BD Eclipse Needle may disengage, posing a needlestick injury risk.

    Product
    Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter The Arrow(r) 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 limite
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2305-2017·2017-06-14

    Arrow International Recalls Central Venous Catheter Kits Due to Needlestick Risk

    Arrow International is recalling specific central venous catheter kits because the packaged BD Eclipse Needle may disengage, posing a needlestick injury risk.

    Product
    ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit The Arrow(r) 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 o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2294-2017·2017-06-14

    Arrow International Recalls Femoral Arterial Line Catheterization Kits

    Arrow International is recalling specific femoral arterial line catheterization kits due to reports of safety cover disengagement and needlestick injuries associated with packaged BD Eclipse Needles.

    Product
    Femoral Arterial Line Catheterization Kit The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2307-2017·2017-06-14

    Arrow International Recalls Hemodialysis Catheterization Kits

    Arrow International Inc is recalling specific hemodialysis catheterization kits due to a lack of clinical data supporting the antimicrobial surface's effectiveness in preventing infections.

    Product
    ARROWg+ard Blue You-Bend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions The Arrow(r) 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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2170-2017·2017-06-07

    Arrow VPS Access Kit Recalled for Missing Dressing Information

    Arrow International is recalling VPS Access Kits because they lack required information regarding the included 3M Tegaderm CHG dressing.

    Product
    Arrow(R) VPS(R) Access Kit for use with 4 and 5 Fr. Peripherally Inserted Central Venous Catheters
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1879-2017·2017-05-03

    Arrow International Recalls Central Venous Catheter Kits Due to Hub Voids

    Arrow International is recalling 310 units of Arrowg+ard Blue Plus Central Venous Catheterization Kits due to possible voids in the catheter hub that could lead to interlumen crossover.

    Product
    Pressure Injectable Arrowg+ard Blue Plus Multi-Lumen Central Venous Catheterization Kit. Permits venous access to central circulation by way of subclavian, jugular and femoral veins. The ARROWg+ard technology is intended to provide protection against catheter-related bloodstream
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1705-2017·2017-04-12

    Arrow International Recalls PIC Catheters Due to Labeling Error

    Arrow International is recalling 1,351 CG+ Arrow PIC Catheters due to a labeling error where lidstock and banner card codes do not match.

    Product
    The CG+ Arrow PIC Catheters permit venous access to the central circulation through a peripheral vein.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1228-2017·2017-03-01

    Arrow International Recalls Vascular Catheter Introduction Kits Due to Flaring Sheaths

    Arrow International Inc is recalling 215,703 vascular catheter introduction kits nationwide because complaints were received regarding peel away sheaths flaring.

    Product
    Vascular catheter introduction kit The PICC is indicated for short or long term peripheral access to the central Venous system for intravenous therapy, blood sampling, infusion and power injection of contrast media.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0331-2017·2016-11-09

    Arrow Hands-Off Infusion Port Thermodilution Catheter Recalled for Labeling Inconsistency

    Arrow International Inc is recalling specific lots of Hands-Off Infusion Port Thermodilution Catheters due to a labeling inconsistency. The recall covers 330 units in the US and 1,031 units outside the US.

    Product
    HANDS-OFF Infusion Port Thermodilution Catheter consists of the Arrow IPTD thermodilution catheter enclosed in a contamination shield (Arrow Cath-Gard) with integral flushing/balloon test chamber, enabling the practitioner to prepare, test, and insert the catheter without exposin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2911-2016·2016-10-12

    Arrow Recalls Walrus Arterial Embolectomy Catheters Due to Labeling Errors

    Arrow International Inc is recalling 2,425 Walrus Arterial Embolectomy Catheters nationwide due to incorrect labeling.

    Product
    Walrus Arterial Embolectomy Catheter The arterial embolectomy catheter is intended for use in removing arterial emboli.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2774-2016·2016-09-21

    Arrow Select Kit Recall Due to Component Molding Abnormality

    Arrow International Inc. is recalling 6,121 Arrow Select Kit units due to a component molding abnormality reported by a supplier.

    Product
    Catheter, Intravascular, Therapeutic, Short-Term Less than 30 days The Arrow CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2773-2016·2016-09-21

    Arrow Single-Lumen Catheters Recalled for Packaging Component Molding Abnormality

    Arrow International Inc. is recalling 6,121 units of Arrow Single-Lumen Catheters due to a molding abnormality in the packaging component supplied by a vendor.

    Product
    Catheter, Percutaneous The Arrow Single-Lumen Catheter permits venous access to the central circulation.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2771-2016·2016-09-21

    Arrow International Recalls Select Kit Products Due to Molding Abnormality

    Arrow International is recalling 6,121 units of Select Kit products due to a component molding abnormality reported by a supplier.

    Product
    Catheter, Intravascular, Therapeutic, Long Term Greater than 30 days. An access kit only, contains no base components
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2772-2016·2016-09-21

    Arrow Select Kit Ultrasound Catheters Recalled for Packaging Molding Abnormality

    Arrow International Inc. is recalling 6,121 units of Arrow Select Kit ultrasound catheters due to a component molding abnormality in the packaging.

    Product
    Cather, Ultrasound, Intravascular The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2741-2016·2016-09-14

    Arrow Radial Artery Catheterization Kits Recalled for Shipping Labeling Error

    Arrow International Inc. is recalling 690 Radial Artery Catheterization Kits due to a shipping carton labeling error. The kits were distributed to Ohio, Indiana, Tennessee, North Carolina, and Kentucky.

    Product
    Radial Artery Catheterization Kit with Sharps Safety Features Permits access to the peripheral arterial circulation. The safety feature is intended to help minimize the risk of sharps injuries when using the device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2740-2016·2016-09-14

    Arrow Arterial Line Catheterization Kits Recalled for Shipping Labeling Error

    Arrow International Inc. is recalling 690 Arterial Line Catheterization Kits due to a shipping carton labeling error. The kits were distributed nationwide to five states.

    Product
    Arterial Line Catheterization Kit with Sharps Safety Features Permits access to the peripheral arterial circulation or to other small vessels.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2202-2016·2016-07-20

    Arrow Femoral Arterial Line Catheterization Kit Recalled for Labeling Error

    Arrow International Inc. is recalling 50 units of Femoral Arterial Line Catheterization Kits due to shipping carton labeling errors.

    Product
    Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material ASK-04018-VUH Product Usage: The Arrow arterial catheterization device permits access to the peripheral arterial circulation.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2201-2016·2016-07-20

    Arrow Recalls Femoral Arterial Catheterization Kits Due to Labeling Error

    Arrow International Inc is recalling 50 femoral arterial catheterization kits because some shipping cartons contained the wrong product model.

    Product
    Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material ASK-04018-VUH Product Usage: The Arrow arterial catheterization device permits access to the peripheral arterial circulation.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2136-2016·2016-07-13

    Arrow Recalls Central Venous Catheters Due to Length Mismatch

    Arrow International Inc. is recalling specific lots of central venous catheters because kits labeled for 20 cm catheters may contain 16 cm catheters.

    Product
    ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER. Product Usage: Indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring cental venous access including, but not limited to: multip
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1064-2016·2016-03-16

    Arrow Recalls Percutaneous Sheath Introducer Sets Due to Packaging Damage

    Arrow International Inc. is recalling Super Arrow-Flex Percutaneous Sheath Introducer Sets because packaging damage may compromise sterility, posing a potential infection risk.

    Product
    Super Arrow-Flex Percutaneous Sheath Introducer Sets REF CL-07035 or CL-07635 or CL-07735 or CL-07835 Super Arrow-Flex Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port and Radiopaque Tip Marker Band Contents: 1: . . . . . . . . . Sheath*: *** S
    Category
    Medical Device
    Distribution
    Distributed nationwide