CLASS II ONGOING Device recall · Reported 24 Apr 2024 · FDA Enforcement Report
Smiths Medical Medfusion Guide Barrel Clamp recalled
Smiths Medical ASD is recalling Smiths Medical Medfusion Guide Barrel Clamp. The recall was initiated on 19 Dec 2023 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-1543-2024
- FDA event ID
- 93771
- Recalling firm
- Smiths Medical ASD, Minneapolis, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 19 Dec 2023
- FDA classified
- 15 Apr 2024
- Reported
- 24 Apr 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Other Medical Devices
Timeline
| 19 Dec 2023 | Recall initiated by company | |
| 15 Apr 2024 | Classified by FDA | +118 days |
| 24 Apr 2024 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a molding defect that could potentially lead to slippage of the spring within the barrel clamp assembly. If this occurs, it could result in the inability of the pump to recognize a syringe or the pump may misidentify the size of the syringe loaded.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
Smiths Medical Medfusion Guide Barrel Clamp, Item number G6000716
Where it was distributed
Worldwide distribution.
Questions about this recall
Is Smiths Medical Medfusion Guide Barrel Clamp recalled?
Yes. Smiths Medical ASD recalled Smiths Medical Medfusion Guide Barrel Clamp on 19 Dec 2023. The recall is Class II and its status is Ongoing. Recall number Z-1543-2024.
Why was it recalled?
Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a molding defect that could potentially lead to slippage of the spring within the barrel clamp assembly. If this occurs, it could result in the inability of the pump to recognize a syringe or the pump may misidentify the size of the syringe loaded.
Which lots are affected?
Lot Numbers: P0407365, P0486670, P0561740
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 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 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.
More recalls from Smiths Medical ASD
All 284| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Cadd Solis Hspca Pump ***Updated 5/27/26*** Scope updated recalled | Smiths Medical ASD | Lead & Heavy Metals | Nationwide |
| Device | CLASS I | Cadd-Solis Infusion Pump recalled by Smiths Medical ASD | Smiths Medical ASD | Other | Nationwide |
| Device | CLASS I | CADD Solis VIP Ambulatory Infusion Pump recalled by Smiths Medical ASD | Smiths Medical ASD | Other | Nationwide |
| Device | CLASS I | Cadd-Solis VIP Ambulatory Infusion Pump recalled by Smiths Medical ASD | Smiths Medical ASD | Lead & Heavy Metals | Nationwide |
| Device | CLASS I | Cadd-Solis Hpca Ambulatory Infusion Pump recalled by Smiths Medical ASD | Smiths Medical ASD | Lead & Heavy Metals | Nationwide |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |