Recall Z-0967-2017 ยท KNX Collector, Urine, (And Accessories) For Indwelling Catheter
C.R. Bard, Inc.
SURESTEP Tray, BARDEX I.C. COMPLETE CARE, Urine Meter, Temperature STATLOCK Stabilization Device
| Date | Jul 11, 2016 |
| Status | Terminated |
| Reason | The product contained a latex catheter instead of a silicone catheter. |
| Root cause | Labeling mix-ups |
| Action | Bard Medical sent an Urgent : Medical Device Product Recall Letter dated July 11, 2016, to all affected customers. The letter requested that they check inventory and quarantine product, and if the product had been further distributed, they need to conduct a sub-recall. The letter included a reply form to be returned. For further questions, please call (770) 784-6220. |
| Quantity | 2690 units |
| Distribution | US Distribution to the states of : CA, CT, FL, GA, IL, IN, KS, KY, MD, MA, MI, NE, NV, NJ, NM, NY, OR, SC, TN, TX, UT, VA, WA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.