PermaLife PL120NRecalls & reported problems
Origen Biomedical, Inc. · PermaLife Cell Culture Bag, 120ml, with SCD Tubing · Class U
Data updated Oct 16, 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 10816203023244), received between Dec 6, 2024 and Dec 6, 2024 — 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 16, 2026.
Reports received per month
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.
MalfunctionDec 6, 2024Leak/Splash; Leak/Splash
THERE WAS A PINHOLE THAT LED TO MATERIAL LEAKAGE FROM A PL120N CELL CULTURE BAG FOLLOWING REMOVAL OF THE BAG FROM INCUBATION. THIS LEAKAGE LED TO THE BATCH OF PRODUCT TO BE TERMINATED AND A SUBSEQUENT DELAY IN PATIENT TREATMENT GREATER THAN 24 HOURS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20870086 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page