FDA recall Z-0957-2019

Cardinal Health 200, LLC · Class II · device

Product

Curity All Purpose Sponges, Non-woven, 4 Ply, 4" x 4" (10.2 cm x 10.2 cm) Product Code: 8044 - Product Usage: Ideal for applying ointments, prepping, wiping needles, cleaning slides and more Rayon/polyester blend construction Highly absorbent.

Reason for recall

Curity All Purpose Sponges were not sterilized and distributed

Distribution

Worldwide distribution - US Nationwide and countries of Canada, Colombia.

Key facts

Status
Terminated
Initiation date
2018-12-27
Report date
2019-03-06
Termination date
2020-06-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Mansfield, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0957-2019