Recall Z-0957-2019 ยท NAB Gauze / Sponge,Nonresorbable For External Use
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.
| Date | Dec 27, 2018 |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.