Medfusion Syringe Pump, Model 4000-XXXX-XX: a) 0100-50, b) 0100-249, c) 0101-50, d) 0101-51, e) 0101-78, f) 0101-249, g) 0105-51, h) 0105-78, i) 0105-249, j) 0106-00, k) 0106-01, l) 0106-231, m) 0107-01, software versions: v3, v4, v5, and v6
Class I - DangerousWhat Should You Do?
- Check if you have this product: a) 0100-50, UDI/DI 10610586035326; b) 0100-249, UDI/DI 10610586033124; c) 0101-50, UDI/DI 10610586040054; d) 0101-51, UDI/DI 10610586040818; e) 0101-78, UDI/DI 10610586040788; f) 0101-249, UDI/DI 10610586040078; g) 0105-51, UDI/DI 10610586043567; h) 0105-78, UDI/DI 10610586043574; i) 0105-249, UDI/DI 10610586043581; j) 0106-00, UDI/DI 15019517070750; k) 0106-01, UDI/DI 15019517069624; l) 0106-231, UDI/DI 15019517070996; m) 0107-01, UDI/DI 15019517154313; All serial numbers
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Smiths Medical ASD Inc.
- Reason for Recall:
- A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the force sensor calibration shift is large enough, the pump will display a System Failure Alarm (including Force Sensor BGND Test, Force Sensor Bridge Test, or Force Sensor Test). However, if the calibration shift is not large enough to trigger a System Failure Alarm, the threshold to detect an occlusion may increase, increasing the time to occlusion detection, or the threshold may decrease, leading to false occlusion alarms. Although shifts in the force sensor calibration may occur over time with any device, an increased potential for such shifts has been reported in devices produced before April 2022 due to mechanical interference between parts of the plunger head assembly. Out of an abundance of caution, we are notifying all customers of this potential issue.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Medfusion Syringe Pump, Model 4000-XXXX-XX: a) 0100-50, b) 0100-249, c) 0101-50, d) 0101-51, e) 0101-78, f) 0101-249, g) 0105-51, h) 0105-78, i) 0105-249, j) 0106-00, k) 0106-01, l) 0106-231, m) 0107-01, software versions: v3, v4, v5, and v6
Product Codes/Lot Numbers:
a) 0100-50, UDI/DI 10610586035326; b) 0100-249, UDI/DI 10610586033124; c) 0101-50, UDI/DI 10610586040054; d) 0101-51, UDI/DI 10610586040818; e) 0101-78, UDI/DI 10610586040788; f) 0101-249, UDI/DI 10610586040078; g) 0105-51, UDI/DI 10610586043567; h) 0105-78, UDI/DI 10610586043574; i) 0105-249, UDI/DI 10610586043581; j) 0106-00, UDI/DI 15019517070750; k) 0106-01, UDI/DI 15019517069624; l) 0106-231, UDI/DI 15019517070996; m) 0107-01, UDI/DI 15019517154313; All serial numbers
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0079-2024
Related Recalls
Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.
Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.
There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.