Z-3200-2018 Class II Terminated

Recalled by Arrow International Inc — Reading, PA

Recall Details

Product Type
Devices
Report Date
September 26, 2018
Initiation Date
July 17, 2018
Termination Date
December 2, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1257 total

Product Description

5.5 Fr x 40 cm 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.

Distribution Pattern

The products were distributed to the following US states: AL, AZ, CA, GA, MA, MD, ME, MI, NY, PA, RI, SC, VA, and WA.

Code Information

23F17K0753, 23F17L0299