PlainRecalls
FDA Devices Moderate Class II Terminated

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: multiple infusions of fluids, medications, or chemotherapy, infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values, frequent blood sampling or blood/blood component infusions, infusion of incompatibl

Reported: July 13, 2016 Initiated: June 2, 2016 #Z-2136-2016

Product Description

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: multiple infusions of fluids, medications, or chemotherapy, infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values, frequent blood sampling or blood/blood component infusions, infusion of incompatible medications, central venous pressure monitoring, lack of usable peripheral IV sites, replacement of multiple peripheral sites for IV access and injection of contrast media.

Reason for Recall

Arrow is recalling these products due to the possibility that although the kit is labeled as containing a 20 cm catheter, a 16 cm catheter may be packaged in the kit.

Details

Recalling Firm
Arrow International Inc
Units Affected
1, 170 units
Distribution
US Nationwide Distribution: in the states of MA, CA, IL, TN, IL
Location
Reading, PA

Frequently Asked Questions

What product was recalled? ▼
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: multiple infusions of fluids, medications, or chemotherapy, infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values, frequent blood sampling or blood/blood component infusions, infusion of incompatible medications, central venous pressure monitoring, lack of usable peripheral IV sites, replacement of multiple peripheral sites for IV access and injection of contrast media.. Recalled by Arrow International Inc. Units affected: 1, 170 units.
Why was this product recalled? ▼
Arrow is recalling these products due to the possibility that although the kit is labeled as containing a 20 cm catheter, a 16 cm catheter may be packaged in the kit.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 13, 2016. Severity: Moderate. Recall number: Z-2136-2016.

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