INTERLINK 1C8333Recalls & reported problems
Baxter International Inc. · Blood Bag Spike, Injection Site · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00085412013619), received between Jul 23, 2021 and Aug 19, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (2 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.
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 19, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT PARTICULATE MATTER (PM) WAS OBSERVED WITHIN AN INTERLINK SYSTEM BLOOD BAG SPIKE INJECTION SITE. THE PM WAS FURTHER DESCRIBED AS "WHITE DISCOLORATION AROUND THE SEPTUM". THIS ISSUE WAS OBSERVED WHEN REMOVING THE DEVICE FROM THE ORIGINAL PACKAGING, PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12344424 ↗MalfunctionJul 23, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED PARTICULATE MATTER (PM) WAS OBSERVED WITHIN AN INTERLINK SYSTEM BLOOD BAG SPIKE INJECTION SITE. THE PM WAS FURTHER DESCRIBED AS WHITE DISCOLORATION AROUND THE SEPTUM. THIS ISSUE WAS OBSERVED AFTER SPIKING PRIOR TO PATIENT USE OF THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12221474 ↗
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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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