Baxter EXACTAMIX Inlet, Non-Vented, High-Volume Inlet, REF H938173 Product 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 is recalling specific lots of EXACTAMIX Inlet components (model REF H938173) used in the Exacta-Mix 2400 Compounding System. The recalled units were over-labeled with either blank labels or labels showing extended expiration dates. Approximately 98,700 units were distributed worldwide, including in the United States, across five specific lot numbers: 802277, 802278, 802383, 802384, and 802385.
The concern is that if these inlets are used beyond their actual expiration date, there could be product safety issues. The record does not specify what remedial action affected consumers should take.
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: 98700 units Lot/code info: UDI: 00085412475783 Lot Numbers: 802277, 802278, 802383, 802384, 802385
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.