Recall Z-0967-2017
C.R. Bard, Inc. · initiated July 11, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
SURESTEP Tray, BARDEX I.C. COMPLETE CARE, Urine Meter, Temperature STATLOCK Stabilization Device
Codes / lots: NGAQ4149
Reason for recall
The product contained a latex catheter instead of a silicone catheter.
FDA-determined cause: Labeling mix-ups
Action taken
Bard Medical sent an Urgent : Medical Device Product Recall Letter dated July 11, 2016, to all affected customers. The letter requested that they check inventory and quarantine product, and if the product had been further distributed, they need to conduct a sub-recall. The letter included a reply form to be returned. For further questions, please call (770) 784-6220.
Details
- Recall number
- Z-0967-2017
- Initiated
- July 11, 2016
- Terminated
- October 5, 2021
- Product code
- KNX – Collector, Urine, (And Accessories) For Indwelling Catheter
- Quantity
- 2690 units
- Distribution
- 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
- Recalling firm
- C.R. Bard, Inc., Covington, GA