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Cartridge Blood Set 101290Recalls & reported problems

Gambro Renal Products, S.A. de C.V. · The Gambro Cartridge Blood Set is intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems. · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

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

1 FDA recall record name this device's identifier, 1 still open.

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 18, 2026.

Recalls naming this device

  1. Dec 30, 2020Class IIOpen, Classified

    complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.

    Z-1119-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Other SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE devices

All SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page