Device recall: Baxter ONE-LINK Non-DEHP Y-Type Microbore Catheter Extension Set, Bonded Needle-free IV Connector, Neutral Fluid…

Class II FDA enforcement event 87056. Recall start date: 21 Dec 2020. Status in the FDA record: Terminated. Termination date: 11 Jul 2024.

Reason for recall, in the words of FDA

There were customer reports of separation between the tubing and Male Luer Lock Adaptor.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Baxter Healthcare Corporation started this device recall on 21 Dec 2020. The firm address in the FDA record is in Deerfield, IL. FDA put the recall in Class II. FDA event 87056 has 1 product record. The first FDA enforcement report date is 17 Feb 2021. The record gives the status Terminated, with the termination date 11 Jul 2024.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Worldwide distribution - US Nationwide distribution in the states of SC, OH, MI, CA, TX, and the countries of UK, Ireland.

Recalling firm

Baxter Healthcare Corporation, Deerfield, IL.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 87056: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1102-2021	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…	66,800 units	Class II	Terminated	17 Feb 2021

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2020: 916
Share of these events in Class II: 93%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 193

Other events of the firm

Other FDA enforcement events of Baxter Healthcare Corporation
Initiated	Product (first record)	Type	Class	Records
17 Aug 2026	0.9% Sodium Chloride Injection USP 500 mL, VIAFLEX Plastic Containers, with 24 units per case. Baxter Healthcare Corpora	Drug	Class I	1
17 Aug 2026	Dextrose Injection, USP, 70 %, 2000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL, 60016, Made in USA, N	Drug	Class I	1
11 Aug 2026	Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS	Device	Class II	2
6 Aug 2026	Vancomycin Injection, USP in 5% Dextrose, 1 g per 200mL (5 mg/mL), in GALAXY Single-Dose Container, Rx only, Sterile Non	Drug	Class II	17
24 Jul 2026	Cefazolin in Dextrose, Injection, USP, 2g / 100mL (20mg / mL) Single-Dose Infusion Bag in 100mL GALAXY Plastic Container	Drug	Class I	1
30 Jun 2026	Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution Administration Sets	Device	Class I	1
21 May 2026	Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085; Oscillation Lung Expa	Device	Class I	4
22 Apr 2026	Brand Name: Exacta Mix Product Name: Vented Micro-Volume Inlet Model/Catalog Number: H938175 Product Description: Tubing	Device	Class II	1
21 Apr 2026	Adapter for Head Positioning, Model/Catalog Number: 1739994, when used in conjunction with the side rails of the Upper B	Device	Class II	1
18 Feb 2026	Brand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener VS100 Model/Catalog Number: VS100 Software	Device	Class II	1

Baxter Healthcare Corporation: all 193 events

Official channels

FDA enforcement report Z-1102-2021The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 87056. https://recallregister.com/fda/ii/87056/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Worldwide distribution - US Nationwide distribution in the states of SC, OH, MI, CA, TX, and the countries of UK, Ireland.
What quantity of product is in FDA event 87056?: The FDA record gives this quantity: 66,800 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2020 have the same class?: 93% of the 916 device events that started in 2020 are in Class II.