SteriCare Solutions 5280Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850421008907), received between Dec 27, 2023 and Dec 27, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Contamination” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K083042); 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Nov 6, 2023Open, Classified

   Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in a nonsterile product, use of which could cause infection.

   Z-0513-2024 · Root cause: Process control · 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.

• InjuryDec 27, 2023Contamination; Contamination

  ON 08-NOV-23, NURSE ASSIST RECEIVED A COMPLAINT VIA E-MAIL FROM (B)(6) OF THE FOLLOWING EVENT DESCRIPTION FROM E-MAIL: I USED THE NURSE ASSIST SODIUM CHLORIDE SOLUTION FOR IRRIGATION, AND I BECAME ILL FOLLOWING THIS USE. PLEASE LET ME KNOW WHICH SPECIFIC CONTAMINANT (IE BACTERIA) WAS FOUND IN THE SOLUTION. MY DOCTOR DIRECTED ME TO GET THIS INFORMATION FROM NURSE ASSIST ASAP SO HE CAN TREAT ME WITH THE CORRECT ANTIBIOTIC. I AM IMMUNE-COMPROMISED AND BECAME ILL FOLLOWING MY USE OF THIS PRODUCT. I KNOW I USED BOTTLES FROM LOT #22124474 AND LOT #23065735. HOWEVER, I HAVE BEEN USING THIS PRODUCT REGULARLY FOR A WHILE, SO I HAVE ALSO USED BOTTLES FROM OTHER LOTS (I NO LONGER HAVE THOSE BOTTLES, AS THEY WERE DISPOSED OF PRIOR TO THE ANNOUNCEMENT OF THE RECALL, SO I CANNOT PROVIDE ADDITIONAL LOT NUMBERS). I DO HAVE RECORDS OF THE PURCHASES IN MY AMAZON ACCOUNT.

  Patient problems: Bacterial Infection; Respiratory Tract Infection

  MAUDE report 18401983 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083042. One submission often covers many models, so check the product and lot details in each record.

• Z-0511-2024 · Nov 6, 2023 · Open, Classified
  0.9% Sodium Chloride: Brand Name: Product Name/Product Code: MAC MEDICAL: 10ML FILL SYRINGE/9210; NURSE ASSIST: 3ML IV FLUSH SYRINGE/1203-BP, 5ML IV FLUSH SYRINGE/1205-BP, 10ML IV