Device product
Option-vf Urinary Catheter. Female use only. Latex Free. Sterile, Rx only.
Z-2830-2016
Product summary
- Firm
- C.R. Bard, Inc.
- Event
- Event 74712
- Status
- Terminated
- Classification
- Class II
- Quantity
- 274 units
- Official record key
device-enforcement:Z-2830-2016
Official wording
Reason: During an FDA inspection it was found out that the Practical Foley Catheters to be potentially nonsterile.
Code information: Device Listing No.: D022512. CatalogNo.: FV14218. Lot No.: P1007637, P1007638, P1007461. Exp Date: 08/01/2016.
Distribution pattern: US Distribution to the states of : AL, CA, CO, FL, IL, IN, MA, MD, NJ, NY, OR, PA, TN, WA, and WI.
Derived failure modes
-
Unknown
During an FDA inspection it was found out that the Practical Foley Catheters to be potentially nonsterile.