FDAClass IIOctober 2, 2019

8.5 Fr. X 10 cm ARROW+gard Blue PSI Kit Cath-Gard for recall

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…

Why was 8.5 Fr. X 10 cm ARROW+gard Blue PSI Kit Cath-Gard for recalled?

Products may contain the incorrect banner card within the kit

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?

Lot Number: 13F18H0610

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…
Recalling firm
Arrow International Inc
Quantity
520 eaches
Distribution
US Nationwide distribution.
Recall date
October 2, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls