Recalls for Catheter, Urological (antimicrobial) And Accessories

Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or local and/or systemic allergic reaction

Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or local and/or systemic allergic reaction

Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or local and/or systemic allergic reaction

Some of the devices may function incorrectly resulting in no temperature display or erratic temperatures being displayed on the temperature monitoring devices.

There is potential for packaging defects that may impact the sterile barrier.

There is potential for packaging defects that may impact the sterile barrier.

There is potential for packaging defects that may impact the sterile barrier.

There is potential for packaging defects that may impact the sterile barrier.

There is potential for packaging defects that may impact the sterile barrier.

There is potential for packaging defects that may impact the sterile barrier.

There is potential for packaging defects that may impact the sterile barrier.

There is potential for packaging defects that may impact the sterile barrier.

potential for urine leakage around the vent on the vented sample port

Incorrect unit labeling. The case label and shelf box are correct, Product Code 63512 and Catheter Size 12 French. The unit label (catheter package) may state Product Code 63516 and Catheter Size 16 French.

On some units the inflation valve labeling is reversed on the Prostate and Bladder balloon inflation ports.

Misbranding; the product labeled as an Antibacterial Hydrophilic Intermittent Catheter, is instead an Antibacterial Intermittent Catheter (no Hydrophilic Coating).

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.

Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume.

Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume.

Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume.

There is potential for a white paper-type residue attached to the catheter.

Specific lots labeled as an Antibacterial Hydrophilic Intermittent Catheter may lack the hydrophilic coating.