Z-0794-2020Class II

ONE-LINK Needle-free IV Connector, Product Codes: 7N8300, 7N8301, 7N8310, 7N8330K, 7N8332K, 7N8334K, 7N8370K...

Name: Z-0794-2020 ONE-LINK Needle-free IV Connector, Product Codes: 7N8300, 7N8301, 7N8310, 7N8330K, 7N8332K, 7N8334K, 7N8370K...
Creator: Baxter Healthcare Corporation
Published: 2019-12-12
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2019-12-12 / Open, Classified / root cause: design

FDA source

Baxter Healthcare Corporation began a recall of ONE-LINK Needle-free IV Connector, Product Codes: 7N8300, 7N8301, 7N8310, 7N8330K, 7N8332K, 7N8334K, 7N8370K, 7N8371, 7N8375K, 7N8376K, 7N8377, 7N8378, 7N8390... on 2019-12-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0794-2020
Classification: Class II
Status: Open, Classified
Initiated: 2019-12-12
Posted: 2020-01-09
Recalling firm: Baxter Healthcare Corporation
Product: 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 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.
Product code: FPA Set, Administration, Intravascular
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.
Root cause tag: design
FDA root cause: Device Design
Action: The firm disseminated an urgent medical device correction notice on 12/12/2019. The notice explained the issue and provided the following actions be taken: 1. Baxter will be tightening its internal specifications for the D mold to produce Luers that target the mid to upper range of the ISO specification (target date December 2019). Additional actions, as needed, will be determined through investigation. 2. If you purchased this product directly from Baxter, complete the enclosed Baxter customer reply form and return it to Baxter by faxing it to 224-270-5457 or scanning and e-mailing it to [email protected], even if you do not have any inventory. Returning the Baxter customer reply form promptly will prevent you from receiving repeat notices. 3. If you purchased this product from a distributor, please note that the Baxter customer reply form is not applicable. If a reply form is provided by your distributor or wholesaler, please return it to the supplier according to their instructions. 4. If you distribute this product to other facilities or departments within your institution, please forward a copy of this communication to them. 5. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please distribute this notification to customers and check the associated box on the reply form. For general questions regarding this communication, contact Baxter Product Surveillance at 800-437-5176, between the hours of 8:00 am and 5:00 pm Central Time, Monday through Friday.
Quantity in commerce: 43,495,400 units
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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0794-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0793-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-01-15	2020-01-09
Z-0794-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-01-15	2020-01-09

Product code FPA

K961225Class IIContinuflo Solution Set/secondary Medication SetBaxter Healthcare Corp / cleared 1996-06-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)