—#164076

Product

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.

FDA product code: LHI — Set, I.V. Fluid Transfer
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K002705
Affected lot / code info: UDI: 00085412475783 Lot Numbers: 802277, 802278, 802383, 802384, 802385

Why it was recalled

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,

Root cause (FDA determination)

Labeling Change Control

Action the firm took

The firm initiated the recall by letter on 04/25/2018. The letter identified the affected product, problem and actions to be taken. the firm requested the return of the product. Distributors were directed to conduct a sub-recall, requesting their customers return the product to the entity from whom they received the product.

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern: Worldwide Distribution - US Distribution

Timeline

Recall initiated: 2018-04-25
Terminated: 2020-12-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #164076. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.