ONE-LINK Needle-free IV Connector, Product Codes: 7N8300, 7N8301, 7N8310, 7N8330K, 7N8332K, 7N8334K, 7N8370K, 7N8371, 7N8375K, 7N8376K, 7N8377, 7N8378, 7N8390, 7N8391, 7N8399 - Product Usage: intended for single patient use with a vascular access device for the administration of drugs and solutions
Check against the official notice below — it lists the full affected range.
Baxter Healthcare Corporation has recalled over 43 million ONE-LINK needle-free IV connector units with product codes 7N8300 through 7N8399 and their variants. The connectors have a manufacturing issue where Continu-Flo sets with male Luer bodies at the lower end of or within ISO specifications require more connection force than expected to fully insert and securely tighten the Luer to the ONE-LINK connector. The affected products were distributed nationwide in the United States and internationally to Bermuda, the Bahamas, Trinidad and Tobago, Grand Cayman, St. Thomas, Guyana, Barbados, Mexico, Canada, and New Zealand.
The recall involves all lots of the affected product codes. The source document does not specify a remedy or instructions for what affected consumers should do regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: Worldwide distribution - US Nationwide distribution and countries of Bermuda, Bahamas, Trinidad and Tobago, Grand Cayman, St. Thomas, Guyana and Barbados, Mexico, Canada, and New Zealand. Quantity: 43,495,400 units Lot/code info: PRODUCT CODE UDI 7N8300 85412091839 7N8301 85412475387 7N8301K 85412499635 7N8310 85412476728 7N8330K 85412613499 7N8332K 85412599625 7N8334K 85412613482 7N8370K 85412613505 7N8371 85412091822 7N8375K 85412613475 7N8376K 85412599601 7N8377 85412091808 7N8378 85412091792 7N8390 85412475417 7N8391 85412475400 7N8399 85412091785 7N8399K 85412478227 All Lots
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.