Recall Z-0727-2017 ยท NAC Dressing, Wound, Hydrophilic
Amd-Ritmed, Inc.
AMD-Ritmed Transparent Dressing - Window with label, 4 " x 4 3/4" (10 cm x 12 cm), Reorder No./Code A60044-W, Sterile -- 200 Dressings per case -- Made in China for AMD-Ritmed Inc. 1200 55th Ave., Lachine, QC H8T 3J8/295 Firetower Road, Tonawanda, NY 14150
| Date | Dec 8, 2016 (initiated Jun 8, 2016) |
| Status | Terminated |
| Reason | The lot of transparent dressing was found to be contaminated (not sterile) based on FDA sampling and analysis. |
| Root cause | Material/Component Contamination |
| Action | URGENT: MEDICAL DEVICE RECALL Letter (dated 6/8/2016) was e-mailed to the consignees on 6/8/2016. The recall is being conducted to the retail level. For questions. please contact AMD Customer Service by phone at 1-800-445-0340 or by e-mail at contactus@amdritmed.com. |
| Quantity | US: 216 cases (200 dressings per case) |
| Distribution | NY, MA, VA, TN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.