Agency classClass IIOur severity:High FDA (Devices)·Z-1609-2013·Announced 2013-07-03

Baxter Recalls Infusor SV Elastomeric Infusion Devices Due to Leak Complaints

Baxter Healthcare is recalling 601,230 Infusor SV Elastomeric Infusion Devices due to increased complaints of leaks at the distal male Luer and Luer cap.

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 (leaking) that poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Baxter Healthcare Corp. is recalling 601,230 units of the Infusor SV Elastomeric Infusion Device. This single-use, disposable elastomeric infusion pump is indicated for patients requiring slow, continuous intravenous, intra-arterial, subcutaneous, or epidural administration of medications at a constant flow rate.

The recall was initiated due to an increase in complaints regarding leaks at the distal male Luer and Luer cap. In response, Baxter implemented enhancements to the blue winged cap to improve the seal between the cap and the Luer.

The affected devices were distributed worldwide, including nationwide in the United States, Puerto Rico, and internationally to Brazil, Colombia, Panama, Mexico, Singapore, Japan, Australia, New Zealand, Hong Kong, India, Thailand, Taiwan, and Korea. The specific lot numbers involved are 08M002, 08N007, 08N029, 08N030, 08N034, 08N069, 08N070, and 09A001.

The recalled product

Product: Brand Name: Coiled Tube Infusors (Portable Elastomeric Infusion Systems). Baxter's Infusor SV Elastomeric Infusion Device Device Listing: D020871 Baxter's lnfusors SV Elastomeric Infusion Device is a single-use, disposable elastomeric infusion pump indicated tor…
Manufacturer: Baxter Healthcare Corp.
Category: Medical Device — Infusion Pump
Hazard: leak
Affected units: 601,230

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 (8)

Product Code: 2C1073KJP Lot Numbers: 08M002
08N007
08N029
08N030
08N034
08N069
08N070
09A001

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 2 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 2 products in this recall →

Same manufacturer · Baxter Healthcare Corp.

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Same hazard · leak