Recall Z-2194-2020— Baxter Healthcare Corporation
Class II · Terminated
Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2020-04-17, terminated 2023-02-07. It names 2 FDA 510(k) clearances: K100364, K070414. Product: Gambro Cartridge Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems.. Reason: Potential disconnection of tubing set..
- Recalling firm
- Baxter Healthcare Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-04-17
- Terminated
- 2023-02-07
- Firm location
- Deerfield, IL, United States
510(k) clearances named in this recall
2 on FDA's record- K100364 — GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520
- K070414 — GAMBRO CARTRIDGE BLOOD SETS
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Gambro Cartridge Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems.
Reason for recall
Potential disconnection of tubing set.
Data sourced from openFDA. This site is unofficial and independent of the FDA.