Agency classClass IIOur severity:High FDA (Devices)·Z-1601-2013·Announced 2013-07-03

Baxter Recalls Multirate Infusor Devices Due to Rupture Complaints

Baxter Healthcare is recalling 3,255,096 Multirate Infusor Devices due to an increase in rupture complaints. The devices are indicated for the intravenous administration of medications.

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 structural defect (rupture) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.

Plain-English summary

Baxter Healthcare Corporation is issuing an urgent product recall for Multirate Infusor Devices. These devices are indicated for the intravenous administration of medications. The recall affects 3,255,096 units distributed nationwide and in Puerto Rico.

The recall is being conducted due to an increase in rupture complaints. Baxter has implemented product and process improvements that have substantially improved product quality, and complaint rates for ruptures have since decreased. The company is ensuring that no affected product remains in the field.

The affected product codes are 2C1154KP, 2C1155KP, 2C9960KP, and 2C9961KP. The lot numbers are 10F030, 10F066, 10H043, 10H104, 10K027, 10K099, 10M090, 10G028, 10J059, 10M019, 10M089, 10F058, 10G069, 10G042, 10J048, and 10M026. The expiration date for these units is 06/30/13.

The recalled product

Product: Brand Name: Multirate Infusor Devices. Indicated for the intravenous administration of medications.
Manufacturer: Baxter Healthcare Corp.
Category: Medical Device — Infusion Pumps
Hazard: device-rupture
Affected units: 3,255,096

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 (3)

Product Codes: 2C1154KP
2C1155KP
2C9960KP

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 7 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 7 products in this recall →

Same manufacturer · Baxter Healthcare Corp.

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Same hazard · device rupture