Recall Z-2830-2016
C.R. Bard, Inc. · initiated July 11, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Option-vf Urinary Catheter. Female use only. Latex Free. Sterile, Rx only.
Codes / lots: Device Listing No.: D022512. CatalogNo.: FV14218. Lot No.: P1007637, P1007638, P1007461. Exp Date: 08/01/2016.
Reason for recall
During an FDA inspection it was found out that the Practical Foley Catheters to be potentially nonsterile.
FDA-determined cause: Device Design
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.
Details
- Recall number
- Z-2830-2016
- Initiated
- July 11, 2016
- Posted by FDA
- September 15, 2016
- Terminated
- March 22, 2017
- Product code
- EZL – Catheter, Retention Type, Balloon
- 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.
- Recalling firm
- C.R. Bard, Inc., Covington, GA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2831-2016 Class II | 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. | 07/11/2016Terminated |