FDAClass IISeptember 27, 2023

Arrow ErgoPack Pressure Injectable One-Lumen PICC recall

Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravascular

Why was Arrow ErgoPack Pressure Injectable One-Lumen PICC recalled?

This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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?

Batch/Lot number 13F22J0617

Product
Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravascular
Recalling firm
ARROW INTERNATIONAL Inc.
Quantity
190 units
Distribution
US Nationwide distribution.
Recall date
September 27, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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