Recall Z-1871-2017 ยท EYZ System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile
C.R. Bard, Inc.
SURESTEP Tray, Bardex I.C. Complete Care Drainage Bag, 2000 ml Drainage Bag, 16 Fr., Sterile.
| Date | Mar 9, 2017 |
| Status | Completed |
| Reason | Misbranded: Product labeled, Not made with natural rubber latex, may in fact contain natural rubber latex. |
| Root cause | Error in labeling |
| Action | Consignees were notified by letter on/about 03/09/2017. |
| Quantity | 5030 units |
| Distribution | CA, CO, FL, GA, IA, IL, IN, KY, LA, MI, MN, MS, NC, NE, NJ, NM, OH, OR, PA, RI, TN, TX, VA and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.