Arrow International Inc: Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during central line insertions.

Agency Publication Date: March 5, 2018

Affected Products

Product: Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters. Permits venous access and catheter introduction to the central circulation.

ASK-09903-ECL 23F16H0387 23F16H0595

Product: Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter, Sharps Safety Features and Maximal Barrier Precautions. Permits venous access and catheter introduction to the central circulation.

ASK-15703-PWBH 13F16K0166

Product: Percutaneous Sheath Introducer Kit with ARROWg+ard Blue Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters. Permits venous access and catheter introduction to the central circulation.

ASK-29803-SJH 13F16K0136

Product: Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features, and Maximal Barrier Precautions. Permits venous access to central circulation.

ASK-42703-PSCH 23F16H0492

Product: Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter and Sharps Safety Features. Permits venous access to central circulation.

ASK-45703-PNCB 23F16H0802

Product: Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter, Sharps Safety Features and Maximal Barrier Precautions. Permits venous access to central circulation.

ASK-45703-PUR1 23F16H0385

Product: Pressure Injectable Two- Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter and Sharps Safety Features. Permits venous access to central circulation.

ASK-45802-PHMW 13F16K0236

Product: Pressure Injectable Multi- Lumen CVC Kit

CDC-15703-P1A 13F16J0336

Product: ARROWg+ard Blue PLUS Pressure Injectable Multi-Lumen CVC Kit. Intended to permit venous access to the central circulation.

CDC-42703-P1A CDC-45703-P1A 13F16H0215 13F16H0216 13F16J0157 13F16J0053 13F16J0182 13F16J0186 13F16K0119 13F16K0266

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 79342

Status: Resolved

Manufacturer: Arrow International Inc

Manufactured In: United States

Units Affected: 9 products (18,124 total)

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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

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