FDAFDA · Food and drugs·Recall number Z-2831-2016
Option-vm Urinary Catheter. Male use only. Latex Free. Sterile, Rx only.
Published September 21, 2016 · Recall initiated: July 11, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
During an FDA inspection it was found out that the Practical Foley Catheters to be potentially nonsterile.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- C.R. Bard, Inc.
- Distributor
- US Distribution to the states of : AL, CA, CO, FL, IL, IN, MA, MD, NJ, NY, OR, PA, TN, WA, and WI.
- Lot
- Device Listing No.: D022515. CatalogNo.: MV39016. Lot No.: P1007642, P1007465, P1007466, P1007643, P1007641, P1007640, P1007468, P1007467. Exp Date: 08/01/2016.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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