CLASS I ONGOING Device recall · Reported 25 Sep 2024 · FDA Enforcement Report
Baxter Exactamix Inlet, Vented, Syringe Inlet recalled
Baxter Healthcare is recalling Baxter Exactamix Inlet, Vented, Syringe Inlet. The recall was initiated on 20 Aug 2024 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3085-2024
- FDA event ID
- 95192
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 20 Aug 2024
- FDA classified
- 19 Sep 2024
- Reported
- 25 Sep 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Device type
- Syringes & Needles
Timeline
| 20 Aug 2024 | Recall initiated by company | |
| 19 Sep 2024 | Classified by FDA | +30 days |
| 25 Sep 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H938175, H938176, used with the ExactaMix and ExactaMix Pro compounders. Particulate matter has been observed within the inlet primary packaging inlet components, including within the sterile fluid path tubing, before use.
Product as listed by the FDA
Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical compounding device
Where it was distributed
Worldwide distribution.
Questions about this recall
Is Baxter Exactamix Inlet, Vented, Syringe Inlet recalled?
Yes. Baxter Healthcare recalled Baxter Exactamix Inlet, Vented, Syringe Inlet on 20 Aug 2024. The recall is Class I and its status is Ongoing. Recall number Z-3085-2024.
Why was it recalled?
Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H938175, H938176, used with the ExactaMix and ExactaMix Pro compounders. Particulate matter has been observed within the inlet primary packaging inlet components, including within the sterile fluid path tubing, before use.
Which lots are affected?
UDI/DI 00085412475813, Lot Numbers: 803807 and lower
Where was it sold?
Worldwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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