High FDA (Devices)·Z-1677-2013·Announced 2013-07-17

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 after storage.

What this means for you

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 medical device defect (leakage) that poses a risk of harm to patients, although the source text does not explicitly report injuries or illnesses.

Plain-English summary

Baxter Healthcare Corp. is recalling specific lots of its elastomeric infusion pumps, including 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 involves approximately 442,770 units across five product codes (2C1008KP, 2C1009KP, 2C1063KP, 2C1087KP, and 2C1156KP) and numerous specific lot numbers.

The recall was initiated 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 only after the pumps have been filled, primed, re-capped, and stored for a period of time, often overnight. The affected products 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 identify any pumps matching the specific product codes and lot numbers listed in the recall notice. Users should stop using the affected devices and contact Baxter Healthcare or their supplier for instructions on replacement or return. The source text does not report any specific injuries or illnesses associated with these leakage incidents.

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 sl
Manufacturer: Baxter Healthcare Corp.
Category: Medical Device — Infusion Pumps
Hazard: leakage
device-defect

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)

*** 1) Product Code: 2C1008KP
Lots: 08M036
08N041
09A030
09B044
09C053
09D018
09E019
09F005
*** 2) Product Code: 2C1009KP
Lots: 08M016
08M035
08M066
09A010
09A052
09A065
09A080
09B038
09B048
09B060

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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.

See all 3 products in this recall →

Same manufacturer · Baxter Healthcare Corp.

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Same hazard · leakage