Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175 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 used in the Exacta-Mix 2400 Compounding System. The recalled inlets from lot numbers 802282 and 802283 were incorrectly over-labeled either with a blank label or with a label showing an extended expiration date. Approximately 75,350 units were distributed worldwide, including in the United States.
The hazard associated with this recall is the risk of using the product beyond its actual expiration date if the incorrect labeling is not identified. The recall record does not specify a remedy or recommended action for affected consumers.
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: 75350 units Lot/code info: UDI: 00085412475806 Lot Numbers: 802282, 802283
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.