FDAFDA · Food and drugs·Recall number Z-0967-2017
SURESTEP Tray, BARDEX I.C. COMPLETE CARE, Urine Meter, Temperature STATLOCK Stabilization Device
Published January 18, 2017 · 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
The product contained a latex catheter instead of a silicone catheter.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- C.R. Bard, Inc.
- Distributor
- US Distribution to the states of : CA, CT, FL, GA, IL, IN, KS, KY, MD, MA, MI, NE, NV, NJ, NM, NY, OR, SC, TN, TX, UT, VA, WA
- Lot
- NGAQ4149
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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