Option-vm Urinary Catheter. Male use only. Latex Free. Sterile, Rx only.
Recall
- Recall Number
- Z-2831-2016
- Event Number
- 74712
- Firm
- C.R. Bard, Inc.
- FEI Number
- 1018233
- Product Code
- EZL
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- July 11, 2016
- Posted
- September 15, 2016
- Terminated
- March 22, 2017
- Address
- 8195 Industrial Blvd NE, Covington, GA, 30014-1497
Description
Option-vm Urinary Catheter. Male use only. Latex Free. Sterile, Rx only.
During an FDA inspection it was found out that the Practical Foley Catheters to be potentially nonsterile.
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 should be forwarded the recall notification letter and Recall& Effectiveness Check Form. If you or the patient using these catheters has had an adverse event related to the recalled catheters, please contact Bard Medical Division Field Assurance at 1-800-526-4455 (option 5, then option 4) or via email at BMD.FieldAssurance@crbard. com.
US Distribution to the states of : AL, CA, CO, FL, IL, IN, MA, MD, NJ, NY, OR, PA, TN, WA, and WI.
274 units