Food, drugs, devices › Baxter Healthcare Corporation

Drug recall: 0.9% Sodium Chloride Irrigation USP 5000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015, NDC 0338-0

FDA enforcement event 84288 · Class II · initiated 19 Nov 2019 · status Terminated · terminated 4 Feb 2021

DrugVoluntary: Firm initiated1 product recordDeerfield, IL

FDA enforcement event 84288 is a drug recall by Baxter Healthcare Corporation of Deerfield, IL, initiated 19 Nov 2019 and classified Class II, with 1 product record.

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. 68% of the 362 drug enforcement events initiated in 2019 carry the same class.

Status: Terminated, terminated 4 Feb 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

"Lack of Assurance of Sterility: Product has the potential to leak."

Distribution

"Nationwide within the United States"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-0517-2020	0.9% Sodium Chloride Irrigation USP 5000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015, NDC 0338-0047-29	22336 bags	Class II	Terminated	27 Nov 2019

Context

68%of 2019 drug events are Class II362 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 drug recalled?

FDA's record gives the reason for recall as: "Lack of Assurance of Sterility: Product has the potential to leak."

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: "Nationwide within the United States"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 4 Feb 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 drug 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.