Recall Z-0013-2019 ยท NAD Dressing, Wound, Occlusive
COVIDIEN LLC
Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
| Date | Aug 1, 2018 |
| Status | Terminated |
| Reason | Potential for product sterility breach due to a compromised or pinched seal defect |
| Root cause | Nonconforming Material/Component |
| Action | On August 1, 2018 Cardinal Health issued Urgent Medical Device Recall notices to U.S. customers via Fed Ex and OUS customers were directly contacted by Quality & Regulatory Affair representatives supporting that country. Customers were advised to take the following actions: 1. Inspect stock and quarantine affected product. 2. Immediately stop using affected product. 3. Return the completed acknowledgment form via fax to 847-689-9101 or 614-652-9648, whether or not you have affected product, as Cardinal Health is required to confirm receipt of this notification from customers, and to prevent f |
| Quantity | 2,730,821 units in total |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K990530 | KERLIX MD ANTIMICROBIAL GAUZE DRESSING The Kendall Company, L.P., Jan 31, 2000 |