BIOPHEN UFH Control Plasma 223101Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

3 other recalls cover devices cleared under the same FDA submission (K051472); 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.

Recalls naming this device

1. Jun 28, 2022Terminated

   Incorrect product labeling was included in the package.

   Z-1743-2022 · Root cause: Under Investigation by firm · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K051472. One submission often covers many models, so check the product and lot details in each record.

• Z-1188-2019 · Mar 19, 2019 · Terminated
  BIOPHEN UFH Control C2, REF 223901
• Z-1189-2019 · Mar 19, 2019 · Terminated
  BIOPHEN UFH Control C1, REF 224101
• Z-1190-2019 · Mar 19, 2019 · Terminated
  BIOPHEN LMWH Control C4, REF 224201