PlainRecalls
FDA Devices Moderate Class II Terminated

4.5 Fr x 40 cm single-lumen PICC Kit, Product Code CDC-44041-VPS2, 5.5 Fr double-lumen PICC Kit, Product Code CDC-44052-VPS2

Reported: September 26, 2018 Initiated: July 17, 2018 #Z-3199-2018

Product Description

4.5 Fr x 40 cm single-lumen PICC Kit, Product Code CDC-44041-VPS2, 5.5 Fr double-lumen PICC Kit, Product Code CDC-44052-VPS2

Reason for Recall

The products may contain the incorrect catheter. Kits that should contain a 4.5 Fr single-lumen catheter may contain a 5.5 Fr double-lumen catheter. Kits that should contain a 5.5 Fr double-lumen catheter may contain a 4.5 Fr single-lumen catheter. This issue may cause a delay in treatment while a replacement catheter is obtained.

Details

Recalling Firm
Arrow International Inc
Units Affected
1257 total
Distribution
The products were distributed to the following US states: AL, AZ, CA, GA, MA, MD, ME, MI, NY, PA, RI, SC, VA, and WA.
Location
Reading, PA

Frequently Asked Questions

What product was recalled?
4.5 Fr x 40 cm single-lumen PICC Kit, Product Code CDC-44041-VPS2, 5.5 Fr double-lumen PICC Kit, Product Code CDC-44052-VPS2. Recalled by Arrow International Inc. Units affected: 1257 total.
Why was this product recalled?
The products may contain the incorrect catheter. Kits that should contain a 4.5 Fr single-lumen catheter may contain a 5.5 Fr double-lumen catheter. Kits that should contain a 5.5 Fr double-lumen catheter may contain a 4.5 Fr single-lumen catheter. This issue may cause a delay in treatment while a replacement catheter is obtained.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 26, 2018. Severity: Moderate. Recall number: Z-3199-2018.