Baxter EXACTAMIX Inlet, Vented, High-Volume Inlet, REF H938174 Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound multiple source ingredients into one final solution.
Check against the official notice below — it lists the full affected range.
Baxter Healthcare Corporation has recalled specific lots of EXACTAMIX Inlet components (Lot Numbers 802279, 802280, and 802281) used in the Exacta-Mix 2400 Compounding System. The recall affects 59,475 units that were distributed worldwide, including in the United States. These inlets were incorrectly over-labeled with either blank labels or labels showing extended expiration dates, which could lead to the product being used past its actual expiration date.
Using these inlets beyond their true expiration date could pose a safety concern. The recall notice does not specify what actions consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The inlets were over-labeled with a blank label, or with a label containing an extended expiration date. If the product is used beyond the expiration date,
Reason for recall: Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The inlets were over-labeled with a blank label, or with a label containing an extended expiration date. If the product is used beyond the expiration date, Distribution: Worldwide Distribution - US Distribution Quantity: 59475 units Lot/code info: UDI: 00085412475790 Lot Numbers: 802279, 802280, 802281
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.