FDAClass IIApril 11, 2018

Arterial Access Tray recall

Arterial Access Tray, introducer catheter; Model: GU-04020

Why was Arterial Access Tray recalled?

The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.

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?

Lots: 13F17A0292, 13F17C0309, 13F17E0359, 13F17G0300, 13F17J0242, 23F16F0623, 23F16G0675; Expiration dates: October 2018 through March 2020

Product
Arterial Access Tray, introducer catheter; Model: GU-04020
Recalling firm
Arrow International Inc
Quantity
1190
Distribution
US nationwide distribution, including Puerto Rico.
Recall date
April 11, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls