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EXACTAMIX recallZ-1908-2018 · Baxter Healthcare Corporation · initiated Apr 25, 2018

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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,

FDA root cause category: Labeling Change Control

What the company is doing

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.

Recall details

Recall number
Z-1908-2018
Status
Terminated
Initiated by the company
Apr 25, 2018
Recalling firm
Baxter Healthcare Corporation
Quantity
98700 units
Product code
LHI
FDA submissions
K002705
Distribution
Worldwide Distribution - US Distribution

Product description

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.

Code information (models, lots, serial numbers)

UDI: 00085412475783 Lot Numbers: 802277, 802278, 802383, 802384, 802385

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

6 devices cleared under K002705 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 79975).

Sources and updates

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