Reported Jan 15, 2020 · Ongoing
ONE-LINK Needle-free IV Connector, Product Codes: 7N8300, 7N8301, 7N8310, 7N8330K, 7N8332K, 7N8334K, 7N8370K, 7N8371,…
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?
- ONE-LINK Needle-free IV Connector
- Product Codes
7N83007N83017N83107N8330K7N8332K7N8334K7N8370K7N83717N8375K7N8376K7N83777N83787N83907N83917N8399 -
- Product Usageintended for single patient use with a vascular access device for the administration of drugs and solutions without needles, thus eliminating the potential for needle-stick injuries during use. This device is an in-line injection site which can be connected to standard male Luer adapters (e.g., syringes or sets) for the continuous or intermittent fluid administration or the withdrawal of fluids
- Lot codes and dates
- PRODUCT CODE UDIAll Lots
7N8300854120918397N8301854124753877N8301K854124996357N8310854124767287N8330K854126134997N8332K854125996257N8334K854126134827N8370K854126135057N8371854120918227N8375K854126134757N8376K854125996017N8377854120918087N8378854120917927N8390854124754177N8391854124754007N8399854120917857N8399K85412478227
- PRODUCT CODE UDI
- Amount recalled
- 43,495,400 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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