PlainRecalls
FDA Devices Moderate Class II Terminated

Arterial Catheterization Kit, Arterial Line Kit with Sharps Safety Features wire, guide, catheter The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels

Reported: June 21, 2017 Initiated: May 9, 2017 #Z-2327-2017

Product Description

Arterial Catheterization Kit, Arterial Line Kit with Sharps Safety Features wire, guide, catheter The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels

Reason for Recall

Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.

Details

Recalling Firm
Arrow International Inc
Units Affected
27, 485 distributed in the U.S, 4,371 distributed Internationally
Distribution
Worldwide Distribution - US (nationwide) and Canada
Location
Reading, PA

Frequently Asked Questions

What product was recalled?
Arterial Catheterization Kit, Arterial Line Kit with Sharps Safety Features wire, guide, catheter The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels. Recalled by Arrow International Inc. Units affected: 27, 485 distributed in the U.S, 4,371 distributed Internationally.
Why was this product recalled?
Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 21, 2017. Severity: Moderate. Recall number: Z-2327-2017.