NA 2C6217Recalls & reported problems
Baxter International Inc. · Two Gang Large Bore Stopcock Manifold with Rotating Male Luer Lock · Class 2
- 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 00085412003856), received between Jun 12, 2026 and Jun 12, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “No Flow” (1 report).
1 other recall cover devices cleared under the same FDA submission (K130245); 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.
Reports received per month
Most reported problems
Device problems
- No Flow1
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.
MalfunctionJun 12, 2026No Flow
IT WAS REPORTED THAT NO FLOW WAS OBSERVED IN AN UNSPECIFIED QUANTITY OF STOPCOCK AND I.V. SOLUTION ADMINISTRATION SETS. THE REPORTER STATED THAT THE STOPCOCK WAS ATTACHED AND PRIMED WHILE CONNECTED TO THE IV SET TUBING; HOWEVER, AFTER CONNECTION TO PATIENT'S PIGTAIL CATHETER, FLUID DID NOT FLOW THROUGH THE STOPCOCK. AS A RESULT, CONTINUOUS MANUAL FLUSHING WAS REQUIRED TO ALLOW FLUID FLOW THROUGH TO THE PIGTAIL EXTENSION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THESE EVENTS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25491900 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K130245. One submission often covers many models, so check the product and lot details in each record.
- Z-0189-2026 · Aug 29, 2025 · Open, ClassifiedCONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, Plus 4-Way Stopcock Extension Set with two CLEARLINK Luer Activated Valve, Pfoduct code
Other Stopcock, i.V. Set devices
- Connecta, Luer-Lok 394910BD Switzerland Sàrl · Stopcock, i.V. Set3 recalls8 reports
- Outlook® 490361B. Braun Medical Inc. · Stopcock, i.V. Set3 recalls0 reports
- Blood Administration Set 490530B. Braun Medical Inc. · Stopcock, i.V. Set2 recalls11 reports
- Medex MX9341LIcu Medical, Inc. · Stopcock, i.V. Set63 reports
- ICU Medical AC135Icu Medical, Inc. · Stopcock, i.V. Set1 recall10 reports
- IV Administration Set 490067B. Braun Medical Inc. · Stopcock, i.V. Set1 recall9 reports
- ICU Medical MC330174Icu Medical, Inc. · Stopcock, i.V. Set1 recall4 reports
- ICU Medical Z2587Icu Medical, Inc. · Stopcock, i.V. Set1 recall3 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.