Medfusion Syringe Pump Recalled Due to Multiple Infusion Control and Alarm Failures
Smiths Medical recalled 58,671 Medfusion Syringe Pump units worldwide due to multiple failures that could interrupt therapy or cause over-infusion, including defective alarms and display errors.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification requires a minimum severity score of 4. The recalled pump models have multiple failures affecting critical alarm systems and infusion delivery that could cause therapy interruption or dangerous over-infusion of medications. Although no illnesses or deaths are reported in the source text, the potential for serious patient harm from these failures justifies the Severe classification.
Plain-English summary
Smiths Medical ASD Inc. is recalling the Medfusion Syringe Pump (11 models) due to multiple issues that could interrupt medication delivery or cause over-infusion. The affected models are: 4000-0100-50, 4000-0101-249, 4000-0101-50, 4000-0101-51, 4000-0101-78, 4000-0105-249, 4000-0105-51, 4000-0105-78, 4000-0106-00, 4000-0106-01, and 4000-0106-231. A total of 58,671 units have been distributed worldwide, including throughout the United States and 41 other countries.
The recalled pumps have been identified with eight separate issues: failure of the Primary Audible Alarm, unanticipated depleted battery alarms, time base alarm malfunctions, intermittent infusion continuation after system failure, clearing of the programmed volume delivered, false alarms for rates below recommended minimums, incorrect bolus or loading dose time displays, and a DNS port communication issue. These failures could result in unintended interruption of therapy or uncontrolled over-infusion of medication.
Healthcare facilities and users in possession of these syringe pumps should immediately stop using affected units and contact Smiths Medical ASD Inc. for instructions. Facilities should verify whether they have any of the recalled models by checking serial numbers against the manufacturer's notification and cease use pending further guidance.
The recalled product
- Product
- Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231
- Manufacturer
- Smiths Medical ASD Inc.
- Category
- Medical Device — Infusion Pump
- Affected units
- 58,671
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)
- Model 4000-0100-50: UDI 061058603532
- Serial Numbers: 2000380
- 2000342
- 2000351
- 2000485
- 2002080
- 2000501
- 2000275
- 2002089
- 2000528
- 2000386
- 2002086
- 2000555
- 2002083
- 2000530
- 2000495
- 2002084
- 2002087
- 2000452
- 2002092
Distribution
Part of a larger recall action
This product is one of 2 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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