Medpro Elastomeric Infusion Pump Recalled for Higher Flow Rate
First Medical Source LLC is recalling 500 units of Medpro Elastomeric Infusion Pumps because they may deliver medication at a higher flow rate than specified, risking over-administration.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The recall is classified as FDA Class I, which meets the rubric criteria for a Critical severity score.
Plain-English summary
First Medical Source LLC is recalling 500 units of Medpro Elastomeric Infusion Pumps, specifically the AccuFlux Model # CT-0020-100H. The recall was initiated because the firm confirmed that the affected lots may have a higher flow rate than specified. The devices are intended for the intravenous, percutaneous, subcutaneous, intra-operative, or epidural administration of medications, including pain management and antibiotic delivery.
The use of these devices may lead to the over-administration of drug solutions to patients. The recall is classified as Class I by the U.S. Food and Drug Administration. The source text notes that this is not a new recall, but the agency is reclassifying it as Class I due to administrative issues.
The affected product is distributed nationwide in the state of Illinois. The specific lot number is 91209. Consumers and healthcare providers should stop using the affected devices and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- Medpro Elastomeric Infusion Pump. AccuFlux, Model # CT-0020-100H. Product Usage: The devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications. It is the responsibility of the…
- Manufacturer
- First Medical Source LLC
- Category
- Medical Device — Infusion Pump
- Affected units
- 500
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 (2)
- AccuFlux
- Lot#: 91209.
Distribution
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