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 and distal male Luer connection.
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 is classified as FDA Class II, and the hazard involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Baxter Healthcare Corp. is recalling specific lots 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, subcutaneous, or epidural routes.
The recall is due to reported incidents of leakage at the connection of the blue winged cap and the distal male Luer. Investigations indicate that the leakage occurs only after the pumps are filled, primed, re-capped, and stored for a period of time, typically overnight.
The affected products include Product Code 2C1700KP (Lots 09C013, 09D023) and Product Code 2C1702KP (Lots 08M005, 08M056, 08N055, 09A029, 09B008, 09B061, 09C015, 09D013, 09D043, 09D081, 09E041, 09E070). These units were distributed worldwide, including in the United States, Puerto Rico, and numerous international markets. Healthcare providers and consumers should check their inventory for these specific product codes and lot numbers and stop using the affected devices.
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
- Hazard
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 (16)
- *** 1) Product Code: 2C1700KP
- Lots: 09C013
- 09D023
- *** 2) Product Code: 2C1702KP
- Lots: 08M005
- 08M056
- 08N055
- 09A029
- 09B008
- 09B061
- 09C015
- 09D013
- 09D043
- 09D081
- 09E041
- 09E070
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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