Recall Z-0380-04 ยท NAD Dressing, Wound, Occlusive
Kendall Healthcare Products Co
Kendall Kerlix A.M.D. Antimicrobial Large Roll, Sterile 6 ply-4.5 in x 4.1 yd Product Number: 3331
| Date | Jul 20, 2004 (initiated Jan 8, 2004) |
| Status | Terminated |
| Reason | Sterility compromised due to lack of package seal integrity |
| Root cause | Other |
| Action | Kendall issued Recall letters by US Mail to all customers on January 8, 2004, requesting product be returne and dealer customers be notified. |
| Quantity | 1 case |
| Distribution | AL, AZ, CA, CO, FL, GA, IL, KY, LA, MA, MD, MN, MO,NC NE, NJ, NY, OH, PA, RI, TN, TX, VA, WA, WI, WV. |
| 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 |