FDA Recall
Terminated
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: Z-0957-2019
·
Initiated December 27, 2018
Recall
- Recall Number
- Z-0957-2019
- Event Number
- 82008
- Firm
- Cardinal Health
- FEI Number
- 3014524790
- Product Code
- NAB
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- December 27, 2018
- Terminated
- June 29, 2020
- Address
- 200 LLC 15 Hampshire St, Bldg 5, Mansfield, MA, 02048-1113
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
Curity All Purpose Sponges were not sterilized and distributed
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
Distribution
Worldwide distribution - US Nationwide and countries of Canada, Colombia.
Quantity
10,400 units (13 cases, 800 units/case)