Merit® Kit 00884450328620Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
All models of Merit Kit (2)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier.
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.
Recalls naming this device
- Sep 20, 2017Terminated
2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product and placed into these dialysis kits.
Z-1144-2018 · Root cause: Mixed-up of materials/components · Recall details · FDA record ↗
Other Dialysis administration kit devices
- Merit® Kit 00884450328613Merit Medical Systems, Inc. · Dialysis administration kit1 recall0 reports
- Medline Industries, Inc. DYNDC3088Medline Industries, Inc. · Dialysis administration kit1 recall0 reports
- Medline Industries, Inc. DYNJ36932AMedline Industries, Inc. · Dialysis administration kit1 recall0 reports
- Medical Action Industries 78791Medical Action Industries Inc. · Dialysis administration kit1 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
- 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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