CLASS II Device recall · Reported 15 Aug 2018 · FDA Enforcement Report
Medfusion Syringe Infusion Pump recalled by Smiths Medical ASD
Smiths Medical ASD is recalling Medfusion Syringe Infusion Pump, containing the Barrel Clamp Guide mechanism, distributed in 26 states. The recall was initiated on 13 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-2662-2018
- FDA event ID
- 80490
- Recalling firm
- Smiths Medical ASD, Minneapolis, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Apr 2018
- FDA classified
- 8 Aug 2018
- Reported
- 15 Aug 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Infusion Pumps
Timeline
| 13 Apr 2018 | Recall initiated by company | |
| 8 Aug 2018 | Classified by FDA | +117 days |
| 15 Aug 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Certain Barrel Clamp Guides may contain a ridge that could potentially lead to spring slippage, resulting in the inability of the pump to recognize a loaded syringe or the pump, misidentifying the size of a loaded syringe.
Product as listed by the FDA
Medfusion Syringe Infusion Pump, containing the Barrel Clamp Guide mechanism
Where it was distributed
US distribution to AL, AZ, CA, DC, FL, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NJ, NM, NY, OH, OK, PA, TN, TX, UT, VA, WA. International distribution to Canada and Lebanon.
AlabamaArizonaCaliforniaDistrict of ColumbiaFloridaIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouriNew JerseyNew MexicoNew YorkOhioOklahoma
Questions about this recall
Why was it recalled?
Certain Barrel Clamp Guides may contain a ridge that could potentially lead to spring slippage, resulting in the inability of the pump to recognize a loaded syringe or the pump, misidentifying the size of a loaded syringe.
Which lots are affected?
Barrel Clamp Guide mechanism number: G6000716; Barrel Clamp Guide lot numbers: P0239588, P0321444, and P0462421
Where was it sold?
US distribution to AL, AZ, CA, DC, FL, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NJ, NM, NY, OH, OK, PA, TN, TX, UT, VA, WA. International distribution to Canada and Lebanon.
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.
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| 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 |
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