FDAFDA · Food and drugs·Recall number Z-1609-2013
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 requiring slow, continuous intravenous, intra-arterial, subcutaneous, or epidural administration of medications at a constant flow rate.
Published July 3, 2013 · Recall initiated: June 7, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Due to an increase in complaints for leaks at the distal male Luer and Luer cap. Baxter implemented enhancements to the blue winged cap to improve the seal between the cap and the Luer.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Baxter Healthcare Corp.
- Distributor
- Worldwide Distribution - USA (nationwide), Puerto Rico, and Internationally to Brazil, Colombia, Panama, Mexico, Singapore Japan, Australia, New Zealand, Hong Kong, India, Thailand, Taiwan, and Korea.
- Lot
- Product Code: 2C1073KJP Lot Numbers: 08M002, 08N007, 08N029, 08N030, 08N034, 08N069, 08N070, 09A001
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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