Reported Feb 24, 2021 · Ongoing
Gambro Cartridge Blood Transport System for Hemodialysis Blood Set, product code 109536 - Product Usage: intended for…
Baxter Healthcare Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Baxter Healthcare Corporation · 1 Baxter Pkwy · Deerfield, IL · 60015-4625
Is this the product you have?
- Gambro Cartridge Blood Transport System for Hemodialysis Blood Set
- product code 109536 - Product Usageintended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems
- Lot codes and dates
- UDI 07332414085216, All lots within expiry
- Amount recalled
- 211155 devices
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Why it was recalled
complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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