Device product
BARD SureStep Foley Tray System Bardex I.C. Complete Care Temperature Sensing Infection Control Foley Catheter with Bard Hydrogel and Bacteria-Guard Silver Alloy Coating. Sterile. Intended for use in the drainage and/or collection and/or measurement of urine.
Z-0800-2019
Product summary
- Event
- Event 81750
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 450 units
- Official record key
device-enforcement:Z-0800-2019
Official wording
Reason: Some SureStep" Foley Tray Systems with product catalog number A319418AM and lot number NGCT1929 contain vented sample ports that may have an increased likelihood of leaking urine from the vent on the sample port.
Code information: Product Code A319418AM; Lot NGCT1929; Exp. Date 11/30/2018
Distribution pattern: US Nationwide Distribution io KY, NE, GA, FL, MS, IN, IL, VA, OK, TX, NM, IL, VA, PA, CA, NV.
Derived failure modes
-
Unknown
Some SureStep" Foley Tray Systems with product catalog number A319418AM and lot number NGCT1929 contain vented sample ports that may have an increased likelihood of leaking urine from the vent on the sample port.