PlainRecalls
FDA Devices Moderate Class II Terminated

Arrow International, Inc. Two-Lumen CVC Kit with Blue Flex Tip Catheter. The multiple lumen catheter permits venous access to the central circulation of patients.

Reported: August 21, 2013 Initiated: July 31, 2013 #Z-1965-2013

Product Description

Arrow International, Inc. Two-Lumen CVC Kit with Blue Flex Tip Catheter. The multiple lumen catheter permits venous access to the central circulation of patients.

Reason for Recall

Arrow is recalling the product due to a labeling inconsistency. One portion of the lidstock states the kit contains a 3-Lumen catheter while the rest of the lidstock correctly identifies the catheter as 2-Lumen.

Details

Recalling Firm
Arrow International Inc
Units Affected
156
Distribution
AL, PA, CT, NC, VA, KS, RI, AZ, NJ, and IL.
Location
Reading, PA

Frequently Asked Questions

What product was recalled?
Arrow International, Inc. Two-Lumen CVC Kit with Blue Flex Tip Catheter. The multiple lumen catheter permits venous access to the central circulation of patients.. Recalled by Arrow International Inc. Units affected: 156.
Why was this product recalled?
Arrow is recalling the product due to a labeling inconsistency. One portion of the lidstock states the kit contains a 3-Lumen catheter while the rest of the lidstock correctly identifies the catheter as 2-Lumen.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 21, 2013. Severity: Moderate. Recall number: Z-1965-2013.