Arrow International Inc: Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.

Agency Publication Date: September 9, 2016

Affected Products

Product: Catheter, Intravascular, Therapeutic, Long Term Greater than 30 days. An access kit only, contains no base components

Lot/Batch Numbers: 23F15L0662,23F15J0260,23F15K0983,23F15G0159,23F15J1102,23F15J0259 23F15C1225,23S15G0973,23F15H1033,23F15F0358,23F15K0345,23F15D1514 23F15C1226,23F15H0919,23F15E1091,23F15H0014,23F15D0241,23F15J0533 23F15E1094,23F15H0020,23F15H0740,23F15K1009,23F15J0431,23F15F1836 23F15H0857,23F15K0012,23F15M0313,23F15G0871,23F15J0285

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Product: Cather, Ultrasound, Intravascular The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters.

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Product: Catheter, Percutaneous The Arrow Single-Lumen Catheter permits venous access to the central circulation.

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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.

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Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 74898

Status: Resolved

Manufacturer: Arrow International Inc

Manufactured In: United States

Units Affected: 4 products (6,121 units in total)

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Sources: FDA iRES · Raw API Response

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Affected Products

Product: Catheter, Intravascular, Therapeutic, Long Term Greater than 30 days. An access kit only, contains no base components

Lot Numbers:

Numbers

Product: Cather, Ultrasound, Intravascular The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters.

Lot Numbers:

Numbers

Product: Catheter, Percutaneous The Arrow Single-Lumen Catheter permits venous access to the central circulation.

Lot Numbers:

Numbers

Lot Numbers:

Numbers