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U.S. Department of Health and Human Services

Class 2 Device Recall IVX Station Reconstitution Transfer Set

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 Class 2 Device Recall IVX Station Reconstitution Transfer Setsee related information
Date Initiated by FirmFebruary 20, 2025
Date PostedApril 04, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1532-2025
Recall Event ID 96422
510(K)NumberK212530 
Product Classification Set, i.V. Fluid transfer - Product Code LHI
ProductIVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: 1 set per White Tyvek Pouch, 5 Tyvek Pouches per shelf box, 10 shelf boxes per case box. IVX Station Reconstitution Transfer Set is used for the reconstitution of drug vials in hospital pharmacies. It is indicated for use with the IVX Station Pharmacy Compounding System.
Code Information Model number: 298921215. UDI Number: 0086000726042101124301840119041525, 0086000726042101124300840119041525, 0086000726042101124301680119041525. Lot number 011243.
Recalling Firm/
Manufacturer		 Omnicell, Inc.
500 Cranberry Woods Dr Ste 400
Cranberry Township PA 16066-5224
For Additional Information Contact
724-741-7700
Manufacturer Reason
for Recall		IVX Station Reconstitution Transfer Sets were shipped in advance of the IVX Station upgrade and not intended for clinical use but are engineering devices intended for use during set up and system calibration. The items were not shipped in a validated packing configuration and sterility cannot be ensured.
FDA Determined
Cause 2		Process control
ActionSingle customer was notified on 02/21/2025 via email and later received the letter via hand delivery on 02/25/2025. The notification instructed the customer that Omnicell personnel will remove the affected units, and any Reconstitution Transfer Sets required for Omnicell use during set up and upgrade will be provided as part of a supply kit and will be marked not for human use. The customer was requested to complete and return the Customer Acknowledgement and Receipt.
Quantity in Commerce3
DistributionDistributed in the US to Alabama
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = LHI
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