Smiths Medical Medfusion syringe pumps may fail to recognize syringes
Smiths Medical syringe pumps with defective barrel clamp guides may fail to recognize or correctly identify loaded syringes, potentially affecting medication delivery accuracy.
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: FDA Class II medical device recall for a risk-of-harm product (syringe pump). The source describes potential medication delivery failure due to syringe misidentification, but does not report any illnesses or injuries.
Plain-English summary
Smiths Medical ASD Inc. is recalling certain Medfusion Model 4000, 3500, and 3010 syringe pumps manufactured or serviced with a defective Barrel Clamp Guide (Part Number G6000716) in specific lot numbers (P0407365, P0486670, and P0561740). The defect is a molding flaw that may allow the spring within the barrel clamp assembly to slip out of position.
If the spring slips, the pump may fail to recognize that a syringe is loaded, or it may incorrectly identify the type or size of the syringe. This could compromise the pump's ability to deliver medication as intended.
Approximately 7,160 pumps have been distributed worldwide. Healthcare facilities using Medfusion pumps should verify their equipment serial numbers against the FDA recall information to determine if they have affected units.
Facilities that identify affected equipment should contact Smiths Medical ASD Inc. for instructions regarding replacement, repair, or device handling.
The recalled product
- Product
- Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
- Manufacturer
- Smiths Medical ASD Inc.
- Category
- Medical Device — Syringe Pump
- Affected units
- 7,160
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)
- UDI/DI 10610586040078
- Serial Numbers: 2035426
- b) 4000-0101-50
- UDI/DI 10610586040054
- Serial Numbers: 2033894
- c) 4000-0101-51
- UDI/DI 10610586040818
- Serial Numbers: 2002706
- 2004098
- 2006133
- 2006382
- 2007411
- 2008160
- 2009040
- 2009070
- 2009661
- 2009709
- 2009723
- 2009734
- 2009997
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 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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