SureStep™ Foley Tray System Bardex® IC Complete Care® A300318ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741073748), received between Mar 21, 2018 and Mar 21, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (1 report).

2 FDA recall records name this device's identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jun 25, 2026Class IIOpen, Classified

   Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.

   Z-3116-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Aug 5, 2021Class IIOpen, Classified

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

   Z-2524-2021 · Root cause: Packaging change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 21, 2018Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE THERE WAS "SOME SORT OF GEL" INSIDE OF THE SYRINGE. THE COMPLAINANT REPORTED THAT IT DID NOT LOOK LIKE WHAT IS NORMALLY PROVIDED.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 7356775 ↗