Baxter Healthcare Corporation: Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a pharmaceutical compounding device

Hazard

Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H938175, H938176, used with the ExactaMix and ExactaMix Pro compounders. Particulate matter has been observed within the inlet primary packaging inlet components, including within the sterile fluid path tubing, before use.

Details from the source

Reason for recall: Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H938175, H938176, used with the ExactaMix and ExactaMix Pro compounders. Particulate matter has been observed within the inlet primary packaging inlet components, including within the sterile fluid path tubing, before use. Distribution: Worldwide distribution. Quantity: 1,548,782 units Lot/code info: UDI/DI 00085412475790, Lot Numbers: 803799 and lower

UPC codes

00085412475790

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.