Food, drugs, devices › Baxter Healthcare Corporation

Device recall: Sterile EXACTAMED Oral Dispenser, Clear, Individually Packaged, 5 mL, Product Code H93876105

FDA enforcement event 79090 · Class II · initiated 6 Feb 2018 · status Terminated · terminated 2 Apr 2021

DeviceVoluntary: Firm initiated1 product recordDeerfield, IL

Baxter Healthcare Corporation (Deerfield, IL) initiated this device recall on 6 Feb 2018; FDA lists 1 product record under event 79090, classified Class II.

FDA defines Class II as 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. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.

Status: Terminated, terminated 2 Apr 2021. Initiation: voluntary: firm initiated. Baxter Healthcare Corporation has 193 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Baxter Healthcare Corporation, Deerfield, IL.

Reason for recall

"Affected lot of 5 mL oral dispensers was packaged in individual pouches that are mislabeled with the incorrect product code (H93876101) and volume (1mL)."

Distribution

"Distributed domestically to IL, MA, MD, OH, SD, TX, VA, WI. Distributed internationally to Canada."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0806-2018	Sterile EXACTAMED Oral Dispenser, Clear, Individually Packaged, 5 mL, Product Code H93876105	2,800 units	Class II	Terminated	7 Mar 2018

Context

92%of 2018 device events are Class II1,074 events that year

1product record in this eventfirm median: 1

193events on this register for the firm

Other enforcement events for 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

All 193 events for Baxter Healthcare Corporation

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Affected lot of 5 mL oral dispensers was packaged in individual pouches that are mislabeled with the incorrect product code (H93876101) and volume (1mL)."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is 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.

Where was the product distributed?

FDA's distribution pattern field reads: "Distributed domestically to IL, MA, MD, OH, SD, TX, VA, WI. Distributed internationally to Canada."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 2 Apr 2021. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.