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.
What this means for you
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
- 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
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.
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