Agency classClass IIOur severity:High FDA (Devices)·Z-1600-2013·Announced 2013-07-03

Baxter Recalls Infusor SV and LV Elastomeric Infusion Devices Due to Rupture Complaints

Baxter Healthcare is recalling Infusor SV and LV Elastomeric Infusion Devices due to an increase in rupture complaints. The recall aims to ensure no affected product remains in the field.

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 structural defect (rupture) in a medical device used for intravenous medication administration, which poses a risk of harm even though specific injuries are not detailed in the source text.

Plain-English summary

Baxter Healthcare Corporation is issuing an urgent product recall for Infusor SV and LV Elastomeric Infusion Devices. These devices are indicated for the intravenous administration of medications. The recall is being conducted due to an increase in complaints regarding product rupture.

The recall covers 3,255,096 units distributed nationwide and in Puerto Rico. Specific product codes and lot codes are listed in the official recall documentation, with an expiration date of 06/30/13. Baxter has implemented product and process improvements that have substantially improved product quality, and complaint rates for ruptures have decreased since these changes.

Baxter is conducting this recall to ensure that no affected product remains in the field. Healthcare facilities and users should stop using the affected devices and follow the instructions provided by Baxter for the return or disposal of the recalled products.

The recalled product

Product: Brand Name: Infusor SV and LV Elastomeric Infusion Devices. Indicated for the intravenous administration of medications.
Manufacturer: Baxter Healthcare Corp.
Category: Medical Device — Infusion Devices
Hazard: rupture
structural-defect
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 (6)

Product Codes: 2C1008KP
2C1009KP
2C1063KP
2C1087KP
2C1156KP
2C1700KP

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 · rupture