Option-vm Urinary Catheter recalled over sterility concerns
- Recall date
- July 11, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- C.R. Bard, Inc. recalls Option-vm Urinary Catheter. Male use only. Latex Free. Sterile, Rx only.
- Recall number
- Z-2831-2016
- FDA classification
- Class II
- Brand / firm
- C.R. Bard, Inc.
- Sold / distributed
- US Distribution to the states of : AL, CA, CO, FL, IL, IN, MA, MD, NJ, NY, OR, PA, TN, WA, and WI.
Why it was recalled
During an FDA inspection it was found out that the Practical Foley Catheters to be potentially nonsterile.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Option-vm Urinary Catheter. Male use only. Latex Free. Sterile, Rx only.
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