FDA Recalls Exacta-Mix 2400 Compounding System for Potential Valve Leaks
Baxter Healthcare is recalling the Exacta-Mix 2400 compounding system due to potential leaking valves on ports 1-4 in certain lots. Affected units have lot numbers 60316024 and higher.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II recall with potential leaking valves and no reported illnesses or injuries. The hazard is theoretical and affects a risk-of-harm product (medical device for pharmacy compounding), meeting the 'High' severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
The FDA is requesting a recall of the Exacta-Mix 2400 compounding system, manufactured by Baxter Healthcare Corporation. The device is used in pharmacies to compound multiple source ingredients into a single solution. Approximately 448,960 units have been distributed worldwide.
Certain lots of valve sets in this device have a potential for leaking on ports 1 through 4. Affected products have lot numbers 60316024 and higher, with expiration dates beginning 04/30/2024.
Healthcare facilities and pharmacies currently using this device should contact Baxter Healthcare Corporation for information regarding inspection, repair, or replacement of affected units.
The recalled product
- Product
- 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.
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- Affected units
- 448,960
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 (2)
- Product Code: H938724 Lot Number 60316024 and higher
- expiry beginning with 04/30/2024 UDI/GTIN: 00085412477183
Distribution
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