CHEMO-AIDE 2N9106Recalls & reported problems
Baxter International Inc. · CHEMO-AIDE Dispensing Pin, Reconstitution/Dispensing Device with 0.2 Micron Hydrophobic/Oleophobic Air-Venting Filter and Female Luer Adapter · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00085412035130), received between Apr 24, 2019 and Nov 17, 2023 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Illegible Information” (6 reports).
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
- Illegible Information6
- Break1
- Device Contamination with Chemical or Other Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- No Patient Involvement1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 17, 2023Illegible Information; Illegible Information
IT WAS REPORTED THAT THE INK ON THE LABELING OF AN UNSPECIFIED QUANTITY OF CHEMO-AIDE DISPENSING PINS WIPED RIGHT OFF MAKING THE LABEL "ALMOST IMPOSSIBLE TO READ". THE ISSUE WAS IDENTIFIED DURING SETUP IN A CLEAN ROOM. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18160869 ↗MalfunctionNov 16, 2023Illegible Information; Illegible Information
IT WAS REPORTED THAT THE INK ON AN UNSPECIFIED QUANTITY OF CHEMO-AIDE DISPENSING PINS WIPED RIGHT OFF AND MADE A HUGE MESS AND MADE IT IMPOSSIBLE TO READ. THIS WAS DISCOVERED PRIOR TO PATIENT USE, UPON RECEIVING THE PRODUCT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18151550 ↗MalfunctionNov 16, 2023Illegible Information; Illegible Information
IT WAS REPORTED THAT THE INK ON AN UNSPECIFIED QUANTITY OF CHEMO-AIDE DISPENSING PINS WIPED RIGHT OFF AND MADE A HUGE MESS AND MADE IT IMPOSSIBLE TO READ. THIS WAS DISCOVERED PRIOR TO PATIENT USE, UPON RECEIVING THE PRODUCT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18150365 ↗MalfunctionNov 16, 2023Illegible Information; Illegible Information
IT WAS REPORTED THAT THE INK ON AN UNSPECIFIED QUANTITY OF CHEMO-AIDE DISPENSING PINS WIPED RIGHT OFF AND MADE A HUGE MESS AND MADE IT IMPOSSIBLE TO READ. THIS WAS DISCOVERED PRIOR TO PATIENT USE, UPON RECEIVING THE PRODUCT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18150136 ↗MalfunctionNov 16, 2023Illegible Information; Illegible Information
IT WAS REPORTED THAT THE INK ON AN UNSPECIFIED QUANTITY OF CHEMO-AIDE DISPENSING PINS WIPED RIGHT OFF AND MADE A HUGE MESS AND MADE IT IMPOSSIBLE TO READ. THIS WAS DISCOVERED PRIOR TO PATIENT USE, UPON RECEIVING THE PRODUCT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18150115 ↗MalfunctionOct 10, 2023Illegible Information; Illegible Information
IT WAS REPORTED THAT THE INK ON THE LABELING OF AN UNSPECIFIED QUANTITY OF CHEMO-AIDE DISPENSING PINS WIPED RIGHT OFF MAKING THE LABEL "ALMOST IMPOSSIBLE TO READ". THE ISSUE WAS IDENTIFIED DURING SETUP IN A CLEAN ROOM. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17908424 ↗MalfunctionJul 28, 2023Break; Break
IT WAS REPORTED THAT THE FEMALE LUER PROTECTIVE CAP OF AN UNSPECIFIED QUANTITY OF CHEMO-AIDE DISPENSING PINS WERE DAMAGED. THIS ISSUE WAS FURTHER DESCRIBED AS, ¿BLUE CAP THAT GOES WITH THE LUER LOCK IN THE DISPENSING PIN, INSERTED TO THE BAG, THE BLUE CAP IS SHREDDING INTO THE LUER LOCK OF THE PIN¿. THIS ISSUE WAS OBSERVED DURING SETUP PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17414910 ↗MalfunctionApr 24, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
THIS REPORT SUMMARIZES <NOE> 2 </NOE> MALFUNCTION EVENTS. IT WAS REPORTED THAT PARTICULATE MATTER (PM) WAS OBSERVED IN THE FLUID PATH OF TWO (2) CHEMO-AIDE DISPENSING PINS. THE PM WAS FURTHER DESCRIBED AS BLUE RESIDUE AND WAS DISCOVERED PRIOR TO PATIENT USE OF THE DEVICE. IN BOTH EVENTS, THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Patient Involvement
MAUDE report 8547268 ↗
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- EXACTAMIX H938739Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall972 reports
- EXACTAMIX H938741Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall710 reports
- EXACTAMIX H938737Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall607 reports
- EXACTAMIX H938724Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall513 reports
- EXACTAMIX H938173Baxter Healthcare Corporation · Set, i.V. Fluid transfer2 recalls260 reports
- EXACTAMIX H938176Baxter Healthcare Corporation · Set, i.V. Fluid transfer2 recalls232 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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