Curity All Purpose Sponges, Non-woven, 4 Ply, 4" x 4" (10.2 cm x 10.2 cm) Product Code: 8044 - P...

FDA Recall #Z-0957-2019 — Class II — December 27, 2018

Recall #Z-0957-2019 Date: December 27, 2018 Classification: Class II Status: Terminated

Product Description

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

Recalling Firm

Cardinal Health 200, LLC — Mansfield, MA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

10,400 units (13 cases, 800 units/case)

Distribution

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

Code Information

Lot Number: 18E190262 Expiration Date: 05/2023

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated