FDAClass IIJune 21, 2017

ARROWg+ard Blue CVC Kit The ARROWg+ard Blue CVCs are recall

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

Why was ARROWg+ard Blue CVC Kit The ARROWg+ard Blue CVCs are recalled?

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 -frequent blood sampling or blood/blood components infusions -infusion of incompatible medications -central venous pressure monitoring lack of usable peripheral IV sites -replacement of multiple peripheral sites for IV access

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
ARROWg+ard Blue CVC Kit The ARROWg+ard Blue CVCs are intended to permit venous access to the central circulation
Recalling firm
Arrow International Inc
Quantity
27,485 units distributed in U.S., 4,371 units distributed internationally
Distribution
Worldwide Distribution - US (nationwide) and Canada
Recall date
June 21, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
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