Baxter EXACTAMIX Inlet, Syringe Inlet, REF H938176 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 used in Exacta-Mix 2400 Compounding Systems. The recalled units—approximately 112,975 units distributed worldwide and in the US—were incorrectly over-labeled with either blank labels or labels showing extended expiration dates. The affected lot numbers are 802284, 802285, and 802286.
Using these inlets beyond their actual expiration date poses a potential hazard. The recall notice does not specify what action affected 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: 112975 units Lot/code info: UDI: 00085412475813 Lot numbers: 802284, 802285, 802286
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.