Device 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 requiring slow, continuous intravenous, intra-arterial, subcutaneous, or epidural administration of medications at a constant flow rate.
Z-1609-2013
Product summary
- Event
- Event 65364
- Status
- Terminated
- Classification
- Class II
- Quantity
- 601,230 total
- Official record key
device-enforcement:Z-1609-2013
Official wording
Reason: 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.
Code information: Product Code: 2C1073KJP Lot Numbers: 08M002, 08N007, 08N029, 08N030, 08N034, 08N069, 08N070, 09A001
Distribution pattern: 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.
Derived failure modes
-
Unknown
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.