Omnicell IVX Station medical device recalled for dose accuracy failures
OmniCell recalls six Omnicell IVX Station devices used for automated pharmaceutical preparation. The devices may not account for scale inaccuracy, potentially allowing incorrect doses to pass quality checks.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a risk-of-harm medical device with potential for incorrect pharmaceutical dosing. However, no illnesses or injuries have been reported, limiting the score to 3 per the rubric: 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
The Omnicell IVX Station is an automated system used in healthcare settings to prepare pharmaceutical admixtures and syringes. OmniCell, Inc. is recalling six affected units with model number 298921373 and serial numbers IVXS000014 through IVXS000019. These units were distributed to locations in Alabama and New York.
The recall was issued because the IVX Station does not account for inherent scale inaccuracy or variability in its internal measurements. As a result, the device may pass preparations as acceptable and permit them to be dispensed even when the actual dose accuracy falls outside the limits specified in the product's labeling.
Healthcare facilities using these specific units should immediately stop using the affected devices and contact OmniCell, Inc. for guidance on remediation or replacement. No illnesses or injuries have been reported to date.
The recalled product
- Product
- Omnicell IVX Station-For use in the automated preparation of pharmaceutical admixtures and syringes Model Number: 298921373
- Manufacturer
- OmniCell, Inc.
- Hazard
- dose-inaccuracy
- medication-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- UDI-DI: 00860006285005 Serial Numbers: IVXS000014
- IVXS000015
- IVXS000016
- IVXS000017
- IVXS000018. IVXS000019
Distribution
Distributed in 2 states:
- AL
- NY
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