Z-0800-2019 Class II Ongoing
FDA device recall Z-0800-2019 was initiated by Bard Medical Division on December 6, 2018 and is designated Class II. Reason for recall: 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 … The recall status is ongoing. Affected quantity: 450 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 13, 2019
- Initiation Date
- December 6, 2018
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 450 units
Product Description
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.
Reason for Recall
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.
Distribution Pattern
US Nationwide Distribution io KY, NE, GA, FL, MS, IN, IL, VA, OK, TX, NM, IL, VA, PA, CA, NV.
Code Information
Product Code A319418AM; Lot NGCT1929; Exp. Date 11/30/2018