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Baxter Healthcare Corporation Recall 90643

Description: The Exacta-Mix 2400 compounding system, manufactured by Baxter Healthcare Corporation, is a compounding device used in the pharmacy to compound multiple source ingredients into one final solution. This device is not intended for direct patient hook-up.

Baxter Healthcare Corporation Recall 90643 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1570-2022
Event ID90643
Event DescriptionThe Exacta-Mix 2400 compounding system, manufactured by Baxter Healthcare Corporation, is a compounding device used in the pharmacy to compound multiple source ingredients into one final solution. This device is not intended for direct patient hook-up.
Product TypeDevices
DistributionUS Nationwide distribution.
Quantity113,840 units
Recall ReasonThere is a potential for leaking valves.
Device Classification20220831
Device Code InfoProduct Code: H938724 Lot Number 60316024 and higher; expiry beginning with 04/30/2024 UDI/GTIN: 00085412477183
Center Classification Date20220824
Recall Initiation Date20220714
Recalling FirmBaxter Healthcare Corporation
Initial Notification Letter
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