SteriCare Solutions 6260Recalls & reported problems
Nurse Assist, Inc. · USP Sterile Water, 250 mL Bottle · Class U
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10850421008775), received between Jun 26, 2024 and Jun 26, 2024 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Recalls naming this device
- 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 · Recall details · FDA record ↗
Most reported problems
Device problems
- Contamination1
Patient problems
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 26, 2024Contamination; Contamination
COMMENTS INCLUDED IN EMAIL RECEIVED FROM COMPLAINTS: WE HAVE CONTINUOUSLY USE THIS PRODUCT TO FLUSH MY HUSBAND'S CATHETER 4 TIMES A WEEK AND HAVE BEEN FOR A VERY LONG TIME. SOMEONE NEEDS TO REACH OUT TO ME ASAP TO FULLY EXPLAIN THE WARNING TO STOP USING IMMEDIATELY. HE HAS BEEN HAVING A LOT OF ISSUES WITH WHITE FLOATING SUBSTANCES CLOGGING HIS CATHETER CAUSING MULTIPLE TRIPS TO THE DOCTOR. MY HOME NUMBER IS (B)(6) AND MY NAME IS (B)(6). WE HAVE TWO ORDERS HERE TO RETURN BUT I'M MORE CONCERNED ABOUT THE FULL REASON OF THE RECALL AND WHAT IS SAFE TO USE IN ITS PLACE STARTING TOMORROW. WHEN ATTEMPTING TO CALL, THERE WAS NO ANSWER AND THE MAILBOX IS FULL SO I COULD NOT LEAVE A MESSAGE AND NO ONE IS ANSWERING. I AM EST SO PLEASE REACH BACK OUT ASAP.
Patient problems: Unspecified Infection
MAUDE report 19614888 ↗
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, Classified0.9% 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
Other Dressing, Wound, Drug devices
- MediHoney® 31815Acell, Inc. · Dressing, wound, drug2 recalls7 reports
- MediHoney® 31515Acell, Inc. · Dressing, wound, drug2 recalls6 reports
- MediHoney® 31805Acell, Inc. · Dressing, wound, drug2 recalls1 death5 reports
- MediHoney® 31535Acell, Inc. · Dressing, wound, drug2 recalls0 reports
- AQUACEL AG FOAM 420681Convatec, Purchasing Department · Dressing, Wound, Drug99 reports
- SteriCare Solutions 6240Nurse Assist, Inc. · Dressing, Wound, Drug1 recall14 reports
- Medline DYND500MLSMedline Industries, Inc. · Dressing, wound, drug1 recall5 reports
- MEDLINE MNK0005Medline Industries, Inc. · Dressing, wound, drug1 recall5 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 · each recall links to the FDA recall notice
- 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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