Option-vm Urinary Catheter. Male use only. Latex Free. Sterile, Rx only.
Reported: September 21, 2016 Initiated: July 11, 2016 #Z-2831-2016
Product Description
Option-vm Urinary Catheter. Male use only. Latex Free. Sterile, Rx only.
Reason for Recall
During an FDA inspection it was found out that the Practical Foley Catheters to be potentially nonsterile.
Details
- Recalling Firm
- C.R. Bard, Inc.
- Units 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.
- Location
- Covington, GA
Frequently Asked Questions
What product was recalled? ▼
Option-vm Urinary Catheter. Male use only. Latex Free. Sterile, Rx only.. Recalled by C.R. Bard, Inc.. Units affected: 274 units.
Why was this product recalled? ▼
During an FDA inspection it was found out that the Practical Foley Catheters to be potentially nonsterile.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 21, 2016. Severity: Moderate. Recall number: Z-2831-2016.
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