Baxter Healthcare Corporation: Medical Device Recall in 2018 - (Recall #: Z-1909-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product 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.

Product Classification:

Class II

Date Initiated: April 25, 2018

Date Posted: May 30, 2018

Recall Number: Z-1909-2018

Event ID: 79975

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,

Status: Terminated

Product Quantity: 59475 units

Code Information:

UDI: 00085412475790 Lot Numbers: 802279, 802280, 802281

Distribution Pattern:

Worldwide Distribution - US Distribution

Voluntary or Mandated:

Voluntary: Firm initiated