FDA recall Z-1795-2020

Product

CareFusion Safe-T-Centesis Catheter Drainage Tray, Sterile, For Single Use Only, Rx only, Catalog Number PIG1280T, UDI Number 01)10885403108402(17) 210930(10)0001304986

Reason for recall

The 8 Fr catheter was manufactured with the 6.9 Fr needle instead of the 8 Fr needle.

Distribution

Domestic distribution to the following states: Alabama, Colorado, Illinois, Massachusetts, Missouri, Oklahoma, Rhode Island, Virginia, and Wisconsin.

Key facts

Status

Terminated

Initiation date

2020-03-26

Report date

2020-05-06

Termination date

2020-08-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Franklin Lakes, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1795-2020