NovaLine BL 11Recalls & reported problems
Bain Medical Equipment (Guangzhou) Co., Ltd. · Class 2
Data updated Oct 13, 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 06948082702105), received between Dec 6, 2021 and Dec 6, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Air/Gas in Device” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Air/Gas in Device1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 6, 2021Air/Gas in Device
"MICROBUBBLES/SMALL AIR IN ARTERIAL LINE OF NOVALINE (AK98 MACHINE CARTRIDGE). NOT FROM PATIENT VASCATH. ANOTHER HD STAFF RECONNECTED THE LINE TO MAKE SURE NOT OPERATOR ERROR. AIR STILL SEEN IN ARTERIAL LINE. SEEMS LIKE AIR IS COLLECTED/TRAPPED IN DIALYZER OR VENOUS CHAMBER AND NOT REACHING PATIENT VIA VENOUS LINE. BAXTER PRODUCT COMPLAINT LINE CALLED, SPOKE WITH (B)(6). THEY WILL SEND SAMPLE RETURN KIT SO WE CAN SEND BACK NOVALINE TO THEM FOR REVIEW." FDA SAFETY REPORT ID# (B)(4).
Patient problems: Insufficient Information
MAUDE report 12953706 ↗
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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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