Device product
Option-vm Urinary Catheter. Male use only. Latex Free. Sterile, Rx only.
Z-2831-2016
Product summary
- Firm
- C.R. Bard, Inc.
- Event
- Event 74712
- Status
- Terminated
- Classification
- Class II
- Quantity
- 274 units
- Official record key
device-enforcement:Z-2831-2016
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.: D022515. CatalogNo.: MV39016. Lot No.: P1007642, P1007465, P1007466, P1007643, P1007641, P1007640, P1007468, P1007467. 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.