Recalls / —
—#151823
Product
SURESTEP Tray, BARDEX I.C. COMPLETE CARE, Urine Meter, Temperature STATLOCK Stabilization Device
- FDA product code
- KNX — Collector, Urine, (And Accessories) For Indwelling Catheter
- Device class
- Class 2
- Medical specialty
- Gastroenterology, Urology
- Affected lot / code info
- NGAQ4149
Why it was recalled
The product contained a latex catheter instead of a silicone catheter.
Root cause (FDA determination)
Labeling mix-ups
Action the firm took
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.
Recalling firm
- Firm
- C.R. Bard, Inc.
- Address
- 8195 Industrial Blvd NE, Covington, Georgia 30014-1497
Distribution
- 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
Timeline
- Recall initiated
- 2016-07-11
- Terminated
- 2021-10-05
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #151823. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.