Gambro Cartridge Blood Set, Product Code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
Reported: June 2, 2021 Initiated: April 14, 2021 #Z-1684-2021
Product Description
Gambro Cartridge Blood Set, Product Code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
Reason for Recall
There is a potential leak between the venous patient connector and patient's hemodialysis access.
Details
- Recalling Firm
- Baxter Healthcare Corporation
- Units Affected
- 17,487 units
- Distribution
- Worldwide distribution - United States distribution and the countries of Canada, Korea, and Norway.
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
Gambro Cartridge Blood Set, Product Code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.. Recalled by Baxter Healthcare Corporation. Units affected: 17,487 units.
Why was this product recalled? ▼
There is a potential leak between the venous patient connector and patient's hemodialysis access.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 2, 2021. Severity: Moderate. Recall number: Z-1684-2021.
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