FDAClass IIApril 18, 2018

Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard recall: Sterility Concern

Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard Technology, Part Numbers: (1) ASK-45541-RWJ4; (2) ASK-45552-RWJ4

Why was Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard recalled?

Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

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 Numbers: (1) 13F17D0187; (2) 13F17D0222, 13F17E0849

Product
Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard Technology, Part Numbers: (1) ASK-45541-RWJ4; (2) ASK-45552-RWJ4
Recalling firm
Arrow International Inc
Distribution
Distributed in all 50 U.S. states and the District of Columbia. Distributed in Bahamas, Canada, Mexico, Panama, and Singapore.
Recall date
April 18, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls