CLASS II Device recall · Reported 30 May 2018 · FDA Enforcement Report
Baxter Exactamix Inlet, Syringe Inlet recalled by Baxter Healthcare
Baxter Healthcare is recalling Baxter Exactamix Inlet, Syringe Inlet. The recall was initiated on 25 Apr 2018 and the FDA has classified it as Class II.
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-1911-2018
- FDA event ID
- 79975
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Apr 2018
- FDA classified
- 22 May 2018
- Reported
- 30 May 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Infusion Pumps
Timeline
| 25 Apr 2018 | Recall initiated by company | |
| 22 May 2018 | Classified by FDA | +27 days |
| 30 May 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The inlets were over-labeled with a blank label, or with a label containing an extended expiration date. If the product is used beyond the expiration date,
Product as listed by the FDA
Baxter EXACTAMIX Inlet, Syringe Inlet, REF H938176 Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound multiple source ingredients into one final solution.
Where it was distributed
Worldwide Distribution - US Distribution
Questions about this recall
Why was it recalled?
Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The inlets were over-labeled with a blank label, or with a label containing an extended expiration date. If the product is used beyond the expiration date,
Which lots are affected?
UDI: 00085412475813 Lot numbers: 802284, 802285, 802286
Where was it sold?
Worldwide Distribution - US 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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 79975This product is part of a recall event; the main page for the event is Baxter Exactamix Inlet, Vented, High-Volume Inlet recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Baxter Exactamix Inlet, Vented, High-Volume Inlet recalled | Baxter Healthcare | Other | IL | |
| CLASS II | Baxter Exactamix Inlet, Non-Vented, High-Volume Inlet recalled | Baxter Healthcare | Other | IL | |
| CLASS II | Baxter Exactamix Inlet, Vented, Micro-Volume Inlet recalled | Baxter Healthcare | Other | IL |
More recalls from Baxter Healthcare
All 570| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Dextrose Injection, USP, 70 % recalled by Baxter Healthcare | Baxter Healthcare | Particulate Matter | Nationwide |
| Drug | CLASS I | 0.9% Sodium Chloride Injection USP, Viaflex recalledSodium Chloride | Baxter Healthcare | Particulate Matter | IL |
| Device | CLASS II | Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Baxter Novum IQ Syringe Pump recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Drug | CLASS II | Clindamycin Phosphate in 0.9% Sodium Chloride Injection recalledClindamycin Phosphate | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
Other Infusion Pumps recalls
All 546| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Baxter Novum IQ Syringe Pump recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS I | Baxter Duo-Vent Solution Set and Male Luer Lock Adapter recalled | Baxter Healthcare | Other | Nationwide |
| Device | CLASS II | Plum Solo Precision IV Pump, v1.0.3 recalled by ICU Medical | ICU Medical | Other | Nationwide |
| Device | CLASS II | Intera Oncology Intera 3000 Hepatic Artery Infusion Pump recalled | Boston Scientific | Packaging Defects | Nationwide |