Smiths Medical Medfusion 4000 Syringe Infusion Pump Recall for Wireless Connectivity Issues
Smiths Medical is recalling Medfusion 4000 Syringe Infusion Pumps with PharmGuard Server Software due to potential wireless network connectivity issues caused by a Radio Module defect.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a technical defect (wireless connectivity) with no reported injuries or illnesses, fitting the criteria for a moderate severity recall involving a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Smiths Medical ASD Inc. is recalling 20,884 Medfusion Model 4000 Syringe Infusion Pumps equipped with PharmGuard Server Software (PGS). The recall affects pumps manufactured prior to November 10, 2017, which were distributed nationwide in the United States and in Canada.
The recall is due to a potential Radio Module issue that may cause wireless network connectivity problems on certain pumps. The Medfusion 4000 pumps are indicated for the administration of fluids requiring precisely controlled infusion rates, including blood, lipids, drugs, and other therapeutic fluids, via various delivery routes such as intravenous and intrathecal.
Customers utilizing PharmGuard Server Software with these specific pumps should contact Smiths Medical ASD Inc. for further instructions on resolving the connectivity issue. The source text does not report any illnesses or injuries associated with this defect.
The recalled product
- Product
- Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSIO
- Manufacturer
- Smiths Medical ASD Inc.
- Category
- Medical Device — Infusion Pump
- Hazard
- Affected units
- 20,884
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 Numbers (Serial Numbers): a. 4000-0100-50 (2000245
- 2000246
- 2000247
- 2000248
- 2000251
- 2000252
- 2000254
- 2000255
- 2000256
- 2000257
- 2000258
- 2000260
- 2000261
- 2000264
- 2000265
- 2000267
- 2000268
- 2000269
- 2000270
- 2000272
Distribution
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