FDA recall Z-3200-2018

Product

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

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

Key facts

Status

Terminated

Initiation date

2018-07-17

Report date

2018-09-26

Termination date

2020-12-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Reading, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3200-2018