Device product
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.
Z-1909-2018
Product summary
- Event
- Event 79975
- Status
- Terminated
- Classification
- Class II
- Quantity
- 59475 units
- Official record key
device-enforcement:Z-1909-2018
Official wording
Reason: 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,
Code information: UDI: 00085412475790 Lot Numbers: 802279, 802280, 802281
Distribution pattern: Worldwide Distribution - US Distribution
Derived failure modes
-
Unknown
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,