Z-0957-2019 Class II Terminated
FDA device recall Z-0957-2019 was initiated by Cardinal Health 200, LLC on Dec 27, 2018 and is designated Class II. Reason for recall: Curity All Purpose Sponges were not sterilized and distributed The recall status is terminated (terminated Jun 29, 2020). Affected quantity: 10,400 units (13 cases, 800 units/case).
Recall Details
- Product Type
- Devices
- Report Date
- Mar 6, 2019
- Initiation Date
- Dec 27, 2018
- Termination Date
- Jun 29, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10,400 units (13 cases, 800 units/case)
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
Distribution Pattern
Worldwide distribution - US Nationwide and countries of Canada, Colombia.
Code Information
Lot Number: 18E190262 Expiration Date: 05/2023
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0957-2019
- openFDA file date
- Oct 19, 2026
- Loaded by RegDataLab
- Oct 21, 2026