Option-vf Urinary Catheter. Female use only. Latex Free. Sterile, Rx only.
FDA device recall Z-2830-2016 · posted 2016-09-15 · Terminated
Recall details
- Recalling firm
- C.R. Bard, Inc.
- Reason for recall
- During an FDA inspection it was found out that the Practical Foley Catheters to be potentially nonsterile.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- EZL
- Quantity affected
- 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.
- Date initiated
- 2016-07-11
- Date posted
- 2016-09-15
- Date terminated
- 2017-03-22
- Location
- Covington, GA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OPTION-VF URINARY CATHETER, FV14218 (K023090) | Opticon Medical, Inc. | 2003-03-19 |