FDA Medical Device Recalls (openFDA)
Cardinal Health 200, LLC: 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.
- Recall number
- Z-0957-2019
- Recalling firm
- Cardinal Health 200, LLC
- 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.
- Status
- Terminated
- Initiated
- 2018-12-27
- Posted
- not on file
- Terminated
- 2020-06-29
- Reason
- Curity All Purpose Sponges were not sterilized and distributed
- Root cause
- Under Investigation by firm
- Action
- Cardinal Health issued Urgent: Medical Device Recall dated 12/27/18 advising of the problem and action to take: inspect segregate and return product. Return the acknowledgment form.The letter provides instructions to direct consignees to notify customers. Questions contact Cardinal Health at 800-292-9332
- Quantity
- 10,400 units (13 cases, 800 units/case)
- Distribution
- Worldwide distribution - US Nationwide and countries of Canada, Colombia.
- Lot, serial or model codes
- Lot Number: 18E190262 Expiration Date: 05/2023
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NAB
- Firm FEI
- 3014524790
- Firm city
- Mansfield
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- 3e6df46828c1
- Size
- 288213574 bytes
- Published
- 2026-10-06
- Read
- 2026-10-07T03:20:25.099Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-14
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 3e6df46828c1, published 2026-10-06