Reported Jan 15, 2020 · Ongoing
Clearlink System Continu-Flo Administration Sets, Product Codes: 2C8519, 2C8537, and 2C8541 - Product Usage:For the…
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?
- Clearlink System Continu-Flo Administration Sets
- Product Codes
2C85192C8537
- and 2C8541 - Product UsageFor the administration of fluids from a container into the patients vascular system through a vascular access device
- Lot codes and dates
- Product Codes
2C8519UDI 000854120489942C8537UDI 00085412048970and 2C8541UDI 00085412071107 All Lots
- Product Codes
- Amount recalled
- 271,014,984 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Continu-Flo sets with male Luer bodies at the lower end of, and within, the ISO specification for outer diameter require a higher than expected connection force to fully inset and securely tighten the Luer to the ONE-LINK connector.
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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