Baxter EXACTAMIX Inlet, Vented, High-Volume Inlet, REF H938174 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.
Recall
- Recall Number
- Z-1909-2018
- Event Number
- 79975
- Firm
- Baxter Healthcare Corporation
- FEI Number
- 1417572
- Product Code
- LHI
- Status
- Terminated
- Root Cause
- Labeling Change Control
- Initiated
- April 25, 2018
- Terminated
- December 16, 2020
- Address
- 1 Baxter Pkwy, Deerfield, IL, 60015-4625
Description
Baxter EXACTAMIX Inlet, Vented, High-Volume Inlet, REF H938174 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.
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,
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.
Worldwide Distribution - US Distribution
59475 units