Arrow International Inc: Products may contain the incorrect banner card within the kit

Agency Publication Date: September 23, 2019

Affected Products

Product: 8.5 Fr. X 10 cm ARROW+gard Blue PSI Kit Cath-Gard for use with 7.5 - 8 Fr.Catheters Product Code: CDC-29803-1A - Product Usage: 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. The ARROWg+ard¿ technology is intended to help provide protection against catheter-related infections. Clinical data have not been collected that demonstrate

Lot Number: 13F18H0610

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Product: Arrow 8.5 Fr. X 16 cm Quad-Lumen Central Venous Catheterization Kit Product Code:AK-42854-P1A - Product Usage: The Arrow Central Venous Catheters are intended to permit venous access to the central circulation by way of the femoral, jugular or subclavian veins.

Lot Number: 13F18H0499

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Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83593

Status: Resolved

Manufacturer: Arrow International Inc

Manufactured In: United States

Units Affected: 2 products (520 eaches; 231 units)

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Sources: FDA iRES · Raw API Response

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Affected Products

Lot Number: 13F18H0610

Lot Numbers:

Number

Lot Number: 13F18H0499

Lot Numbers:

Number