Bard Medical Division: Medical Device Recall in 2019 - (Recall #: Z-0800-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: December 6, 2018

Date Posted: February 13, 2019

Recall Number: Z-0800-2019

Event ID: 81750

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.

Status: Ongoing

Product Quantity: 450 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated