Baxter Elastomeric Infusion Pumps Recalled for Leakage at Luer Connection
Baxter Healthcare is recalling specific lots of elastomeric infusion pumps due to reported leakage at the blue winged cap connection after storage.
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: The recall involves a medical device with a functional defect (leakage) that poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
Baxter Healthcare Corp. is recalling specific units of its elastomeric infusion pumps, including the INFUSOR and FOLFUSOR models. These non-electronic, disposable devices are designed to deliver continuous medication for periods ranging from 30 minutes to 7 days via intravenous, intra-arterial, or subcutaneous routes.
The recall is due to reported incidents of leakage at the connection between the blue winged cap and the distal male Luer. Investigations indicate that this leakage typically occurs after the pumps have been filled, primed, re-capped, and stored for a period of time, such as overnight. The affected product code is 2C4700K, with a total of 4,128 units involved in this recall.
The affected pumps were distributed nationwide in the United States, in Puerto Rico, and internationally to numerous countries including Australia, Canada, Germany, Japan, and the United Kingdom. Healthcare providers and patients should stop using the affected pumps and contact Baxter Healthcare for further instructions or replacements.
The recalled product
- Product
- Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices that deliver continuous medication for periods of 30 minutes up to 7 days. They are designed for medication therapies requiring continuous infusion. The infusion pumps can be utilized for…
- Manufacturer
- Baxter Healthcare Corp.
- Category
- Medical Device — Infusion Pumps
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)
- *** 1) Product Code: 2C4700K
- Lot: 09A014
Distribution
Part of a larger recall action
This product is one of 3 recalled by Baxter Healthcare Corp. 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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