Medfusion Syringe Pump Recalled for Occlusion Detection Calibration Drift
Smiths Medical is recalling Medfusion Syringe Pumps due to force sensor calibration drift that may delay occlusion detection or trigger false alarms. About 67,507 pumps are affected, distributed in the US and Canada.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a medical device with potential risk of delayed occlusion detection or false alarms. It meets the criteria for High severity as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Smiths Medical ASD Inc. is recalling Medfusion Syringe Pumps, Model 4000-XXXX-XX, including multiple specific variants running software versions 3 through 6. Approximately 67,507 pumps have been distributed nationwide in the United States and in Canada.
A force sensor in the occlusion detector may drift out of calibration. This can result in delayed occlusion detection, false occlusion alarms, or system failure alarms. An increased risk of calibration drift has been reported in devices manufactured before April 2022 due to mechanical interference between parts of the plunger head assembly.
Although force sensor calibration shifts may occur over time with any device, the manufacturer and FDA are notifying all customers of this potential issue as a precaution.
The recalled product
- Product
- 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
- Manufacturer
- Smiths Medical ASD Inc.
- Category
- Medical Device — Infusion Pump
- Affected units
- 67,507
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Smiths Medical ASD Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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