CURE MEDICAL K2Recalls & reported problems
Convatec, Purchasing Department · Insertion Kit with universal connector on a 1500 ml collection bag · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00815947020475), received between May 16, 2023 and May 16, 2023 — classified as 1 injury.
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 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Urinary Tract Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PATIENT "SUSPECTS THAT SHE HAS AN ALLERGY TO THE WIPES, THIS HAS CAUSED IRRITATION AND AN INFECTION DUE TO THAT. PT HAS BEEN PRESCRIBED CIPRO". NO OTHER INFORMATION PROVIDED.
Patient problems: Urinary Tract Infection
MAUDE report 16938444 ↗
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- SureStep Intermittent Catheter Tray INTAAIC. R. Bard, Inc. · Catheter care tray1 recall1 report
- Medline DYND10407Medline Industries, Inc. · Catheter care tray1 recall1 report
- Centurion Medical Products Corp IVS3635BMedline Industries, Inc. · Catheter care tray1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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