Recall Z-2830-2016 ยท EZL Catheter, Retention Type, Balloon
C.R. Bard, Inc.
Option-vf Urinary Catheter. Female use only. Latex Free. Sterile, Rx only.
| Date | Sep 15, 2016 (initiated Jul 11, 2016) |
| Status | Terminated |
| Reason | During an FDA inspection it was found out that the Practical Foley Catheters to be potentially nonsterile. |
| Root cause | Device Design |
| Action | C.R. Bard sent an Urgent - Medical Device Product Recall letter dated July 8, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm notifies customers of the recall, provides a clinical risk statement, and gives instructions regarding product disposition. Facilities are instructed to examine their inventory and quarantine any recalled product. The firm requested that customers complete the Recall & Effectiveness Check Form if product is or is not in inventory. If product was further distributed, customers sho |
| Quantity | 274 units |
| Distribution | US Distribution to the states of : AL, CA, CO, FL, IL, IN, MA, MD, NJ, NY, OR, PA, TN, WA, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023090 | OPTION-VF URINARY CATHETER, FV14218 Opticon Medical, Inc., Mar 19, 2003 |