Minicap EZPC4466 (UDI 07332414208264)Recalls & reported problems
Vantive US Healthcare LLC · This device is a plastic disconnect cap for peritoneal dialysis and contains povidone-iodine intended to protect the female Luer connector of the Baxter transfer set. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07332414208264), received between Jan 5, 2026 and Jun 10, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (1 report).
1 other recall cover devices cleared under the same FDA submission (K152129); they may or may not involve this specific model.
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.
Reports received per month
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material1
- Product Quality Problem1
- Tear, Rip or Hole in Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 10, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THERE WAS PARTICULATE MATTER PRESENT INSIDE THE OVERPOUCH OF AN UNSPECIFIED QUANTITY OF MINICAPS. THIS WAS DESCRIBED AS THE ¿MINICAPS WERE SEALED. WHEN OPENING THE MINICAPS, THERE WAS CRYSTALIZED GLUE¿. FURTHER DESCRIBED AS ¿LOOKS LIKE GLUE PIECES ON THE INSIDE OF THE MINICAP¿. THIS WAS IDENTIFIED DURING AN UNSPECIFIED PROCESS STEP OF PERITONEAL DIALYSIS THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25460261 ↗MalfunctionJan 5, 2026Product Quality Problem
IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF MINICAPS WERE ¿DRY¿. THE EVENT WAS FURTHER DESCRIBED AS ¿THE CAPS HAD A WHITE RING ON THE BOTTOM OF THE CAP¿ AND ¿THEY HAD MORE WHITE COLOR¿. THIS OCCURRED BEFORE USE OF THE DEVICES FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23968860 ↗MalfunctionJan 5, 2026Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THERE WAS A HOLE IN THE FOIL PACKAGING OF AT LEAST FIVE (5) MINICAPS. THIS WAS IDENTIFIED BEFORE USE OF THE DEVICES FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23957043 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K152129. One submission often covers many models, so check the product and lot details in each record.
- Z-1213-2023 · Feb 1, 2023 · Open, ClassifiedBaxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P; Accessory to disposable administration set for peritoneal dialysis
Other SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE devices
- MiniCap 5C4482Baxter Healthcare Corporation · SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE3 recalls5 deaths2,961 reports
- MiniCap 5C4483Baxter Healthcare Corporation · SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE4 recalls433 reports
- Safe-Lock® 050-95018Fresenius Medical Care Holdings, Inc. · SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE2 recalls509 reports
- MINICAP WITH POVIDONE-IODINE SOLUTION 5C4466PBaxter Healthcare Corporation · SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE1 recall4 deaths347 reports
- MINICAP EXTENDED LIFE PD TRNS 5C4482ABaxter Healthcare Corporation · SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE193 reports
- UltraSet CAPD Disposable Disconnect Y-Set L5C4366Baxter Healthcare Corporation · SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE100 reports
- stay.safe® 050-95012Fresenius Medical Care Holdings, Inc. · SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE1 recall48 reports
- stay.safe® 050-95004Fresenius Medical Care Holdings, Inc. · SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE1 recall43 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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