FDA-Device2013-11-06Class II

Vented Spike Adapter Product Code 2C0471, Sterile, nopyrogenic. Manufactured by an affiliate of Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield IL 60015 USA. An IV transfer device, used to transfer fluids in pharmacy compounding system.

Baxter Healthcare Corp.
Hazard

Potential tears in the pouch of six lots of Vented Spike Adapter Product Code 2C0471

Sold states
Nationwide distribution.
Affected count
49,344 units
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
Vented Spike Adapter Product Code 2C0471, Sterile, nopyrogenic. Manufactured by an affiliate of Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield IL 60015 USA. An IV transfer device, used to transfer fluids in pharmacy compounding system.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0109-2014

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