Regard™ ABGKT3CC22G-REGRecalls & reported problems
Resource Optimization & Innovation, L.L.C. · Mod Kit Pulset 3cc Syringe 22g x 1" Safety Tip 25u BH (ABG) · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00326053118616), received between Mar 3, 2023 and Mar 3, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Leak/Splash” (1 report).
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 18, 2026.
Most reported problems
Device problems
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 3, 2023Leak/Splash; Leak/Splash
LEAKING FROM THE NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16482056 ↗
Other Arterial Blood Sampling Kit devices
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- MEDLINE ART1070AMedline Industries, Inc. · Arterial blood sampling kit3 recalls0 reports
- MEDLINE ART1180Medline Industries, Inc. · Arterial blood sampling kit2 recalls0 reports
- MEDLINE ART775BMedline Industries, Inc. · Arterial blood sampling kit2 recalls0 reports
- MEDLINE ART890AMedline Industries, Inc. · Arterial blood sampling kit2 recalls0 reports
- Centurion ART155ACenturion Medical Products Corporation · Arterial blood sampling kit2 recalls0 reports
- MEDLINE ART1160Medline Industries, Inc. · Arterial blood sampling kit2 recalls0 reports
- OTHER P42453Medline Industries, Inc. · Arterial blood sampling kit2 recalls0 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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