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.
What this means for you
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 patients
- Manufacturer
- Baxter Healthcare Corp.
- Category
- Medical Device — Infusion Pump
- 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 (8)
- Product Code: 2C1073KJP Lot Numbers: 08M002
- 08N007
- 08N029
- 08N030
- 08N034
- 08N069
- 08N070
- 09A001
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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