Arrow International Inc: Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.; 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 -freq

Agency Publication Date: June 12, 2017

Affected Products

Product: Arterial Catheterization Kit, Arterial Line Kit with Sharps Safety Features wire, guide, catheter The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels

Material number: ASK-04018-CC, ASK-04510-HUM, ASK-04550-UHC, Device Listing D025180

Product: Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, Catheter, Percutaneous The Arrow Single-Lumen Catheter permits venous access to the central circulation

Material number: Ask-04301-WBH Device Listing D040650

Product: 1) Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr., Introducer Catheter 2) Arrow PSI Kit

Material number: ASK-09803-WBH1, ASK-09903-KH, CDC-09803-1A Device Listing E433883

Product: 1) Pressure Injectable Multi-Lumen Central Venous Catheterization Kit 2) Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features 3)Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue Plus (R) Catheter and Sharps Safety Features 4) Multi-Lumen Pressure Injectable Central Venous Catheterization Kit with Blue Flex Tip(R)ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Featur

Material number: ASK-12703-PLV1, ASK-15703-PLV, ASK-15703-PRH, ASK-42703-PRJ, ASK-45703-PRH, ASK-45703-PRWJ1, AK-42703-P1A, AK-45703-P1A, CA-42703-P1A, CA-45703-P1A, CDA-42703-P1A, CDA-42802-P1A, CDA-45703-P1A, Device Listing D040746

Product: 1) Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for short-term or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media, and allows for central venous pressure monitoring

Material number: ASK-45552-RWJ4 Device Listing D213817

Product: Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features. The multiple-lumen catheter permits venous access to the central circulation by the way of the femoral, jugular, or subclavian veins. The ARROWg+ard Blue Plus antimicrobial catheter is intended to help provide protection against catheter-related infections. It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use.

Material number: ASK-45703-AH, CDC-42703-1A, CDC-42703-1A, CDC-42854-1A, CDC-45703-1A, CDC-45703-A1A, CDC-45703-B1A, CDC-45854-1A, CDC-47702-1A Device Listing D213817

Product: 1) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit 2) ARROWg+ard Blue PSI Kit 3) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit 4) ARROWg+ard Blue PSI Kit The MACTM two-Lumen Central Venous Access Device with ARROWg+ard Blue permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins

Material number: CDA-21242-1A, CDA-29803-1A, CDC-21242-1A, CDC-29803-1A, CDC-29903-1A Device Listing D025768

Product: 1) ARROWg+ard Blue You-Blend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions The large-bore two-lumen catheter permits venous access to the central circulation for rapid fluid administration, temporary or acute hemodialysis, apheresis and hemofiltration. It may be inserted into the jugular, subclavia, or femoral veins Catheter, hemodialysis non-implanted

Material number: CDA-22122-U1A, CDC-22141-1A CDC-26142-1A Device Listing D025726

Product: Arrow MAC Two-Lumen Central Venous Access Kit Introducer Catheter The Arrow Two-Lumen Central Venous Access device permits venous access and catheter introduction to the central circulation

Material number: CDC-11242-1A Device Listing D025760

Product: Arrow Multi-Lumen CVC Kit The Arrow Two-Lumen Central Venous Access device permits venous access and catheter introduction to the central circulation.

Material number: CDC-12703-1A, CDC-12802-1A, CDC-15703-1A, CDC-15703-B1A, CDC-15802-1A, Device Listing E426708

Product: ARROWg+ard Blue CVC Kit The ARROWg+ard Blue CVCs are intended to permit venous access to the central circulation

Material number: CDC-24301-1A, CDC-24306-1A Device Listing D025398

Product: Arrow Pressure Injectable PICC Kit Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days 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.

Material number: EU-04041-HPMSB, EU-05052-HPMSB, EU-05041-HPMSB Device Listing D000801

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 77232

Status: Resolved

Manufacturer: Arrow International Inc

Manufactured In: United States

Units Affected: 12 products (27, 485 distributed in the U.S, 4,371 distributed Internationally; 27,485 units distributed in U.S., 4,371 units distributed internationally; 27,485 units distributed in U.S, 4,371 units distributed internationally; 27,485 units distributed in U.S., 4,371 units distributed internationally; 27,485 units distributed in U.S., 4,371 units distributed internationally; 27,485 units distributed in U.S., 4,371 units distributed internationally; 27,485 untis distributed in U.S., 4,371 units distributed internationally; 27,485 units distributed in the U.S., 4,371 units distributed internationally; 27,485 units distributed in U.S., 4,371 units distributed internationally; 27,485 units distributed in U.S., 4,371 units distributed internationally; 27,485 units distributed in U.S., 4,371 units distributed internationally; 27,485 units distributed in U.S., 4,371 units distributed internationally)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.