Z-1102-2021Class II

Baxter ONE-LINK Non-DEHP Y-Type Microbore Catheter Extension Set, Bonded Needle-free IV Connector, Neutral...

Name: Z-1102-2021 Baxter ONE-LINK Non-DEHP Y-Type Microbore Catheter Extension Set, Bonded Needle-free IV Connector, Neutral...
Creator: Baxter Healthcare Corporation
Published: 2020-12-21
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2020-12-21 / Terminated / root cause: manufacturing process

FDA source

Baxter Healthcare Corporation began a recall of Baxter ONE-LINK Non-DEHP Y-Type Microbore Catheter Extension Set, Bonded Needle-free IV Connector, Neutral Fluid Displacement, 5.7 " (14 cm), REF 7N8370K -... on 2020-12-21. FDA classified it as Class II and gives the reason as "There were customer reports of separation between the tubing and Male Luer Lock Adaptor". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1102-2021
Classification: Class II
Status: Terminated
Initiated: 2020-12-21
Posted: 2021-02-09
Terminated: 2024-07-11
Recalling firm: Baxter Healthcare Corporation
Product: Baxter ONE-LINK Non-DEHP Y-Type Microbore Catheter Extension Set, Bonded Needle-free IV Connector, Neutral Fluid Displacement, 5.7 " (14 cm), REF 7N8370K - 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.
Product code: FPA Set, Administration, Intravascular
Reason for recall: There were customer reports of separation between the tubing and Male Luer Lock Adaptor.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: The firm initiated the recall by email on 12/21/2020. The letter requested the following: 1. Locate and remove the affected product from consignee's facility. The product code and lot number can be found on the individual product or shipping carton. 2. Contact Baxter Healthcare Center for Service to arrange for return and credit. 3. Confirm the receipt of the letter by completing the enclosed Baxter customer reply form and return it to Baxter via email
Quantity in commerce: 66,800 units
Distribution: Worldwide distribution - US Nationwide distribution in the states of SC, OH, MI, CA, TX, and the countries of UK, Ireland.
Product codes and lots: UDI: 00085412613505, Lot Numbers: DR18E01023, exp. 5/2/2023; DR18E07053, exp. 5/8/2023; DR19G08023, exp. 7/8/2024; DR19H07015, exp. 8/7/2024; DR19L09030, exp. 12/10/2024; DR20B04020, exp. 2/5/2025

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1102-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1102-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-17	2021-02-09

Product code FPA

K132734Class IINeutral Luer Activated Device (One-Link Needle-Free IV Connector) and Extension SetsBaxter Healthcare Corp / cleared 2013-10-08

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)