Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1610-2013·Announced 2013-07-03

Baxter Recalls Infusor Devices Due to Potential Leaks at Luer Connections

Baxter Healthcare is recalling specific Infusor devices because of increased complaints about 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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically involves a temporary or medically reversible adverse health consequence. The source text cites increased complaints about leaks but does not report specific injuries, hospitalizations, or deaths, fitting the criteria for a moderate severity score.

Plain-English summary

Baxter Healthcare Corp. is recalling approximately 601,230 units of Multiday Infusor, Seven Day Infusor, and Basal/Bolus Infusor devices. The recall is due to an increase in complaints regarding leaks at the distal male Luer and Luer cap. These devices are indicated for patients requiring slow, continuous intravenous, intra-arterial, subcutaneous, or epidural administration of medications.

The affected products 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 recall involves specific product codes and expiration dates ranging from June 2013 to December 2014.

Baxter implemented enhancements to the blue winged cap to improve the seal between the cap and the Luer. Users should check their devices against the listed product codes and expiration dates to determine if they are affected.

The recalled product

Product: Brand Name: Multiday lnfusor, Seven Day lnfusor and the Basal/Bolus lnfusor: Single day Infusor 2 ml/h, Single Day INFUSOR 2 ml/h System, Half Day INFUSOR SV 5 ml/h System, Two Day INFUSOR 2 ml/h System, Two day Infusor 2 ml/h, Multiday Infusor 0.5 ml/h, Multiday…
Manufacturer: Baxter Healthcare Corp.
Category: Medical Device — Infusion Pumps
Hazard: leak
seal-failure
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 (10)

Product Codes: 2C1071KJP
2C1073KJP
2C1075KJP
2C1080KJP
2C1082KJP
2C1955KJP
2C1976KJ. Expiration Dates: 06/30/13
12/31/13
06/30/14
12/31/14

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