Device product
SURESTEP Tray, BARDEX I.C. COMPLETE CARE, Urine Meter, Temperature STATLOCK Stabilization Device
Z-0967-2017
Product summary
- Firm
- C.R. Bard, Inc.
- Event
- Event 75952
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2690 units
- Official record key
device-enforcement:Z-0967-2017
Official wording
Reason: The product contained a latex catheter instead of a silicone catheter.
Code information: NGAQ4149
Distribution pattern: 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
Derived failure modes
-
Unknown
The product contained a latex catheter instead of a silicone catheter.