FDA-Device2014-10-22Class II
15 L Cycler Drainage Bag Product Usage: For use with Baxter Cycler Tubing sets as a peritoneal dialysis accessory.
Baxter Healthcare Corp
Hazard
The large tube clamp used to close the drain tube on the 15 L Cycler Drainage Bag may not fully close the drain tube and may result in leakage.
Sold states
Worldwide Distribution - US Nationwide (including Puerto Rico) and countries of, Canada, Australia, New Zealand, Thailand, Malaysia, Singapore, Korea, Japan, Philippines, Columbia, Ecuador, Austria, Bahran, Belgium, Bosnia & Herzegovina, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Georgia, Germany, Great Britain, Greece, Hungary, Ireland, Isreal, Italy, Jordan, Kazakhstan, Latvia, Luxembourg, Malta, Norway, Oman, Poland, Portugal, Qatar, Russia, Saudi Arabia, Slovakia, South Africa, Spain (including Canary Islands), Sweden, Switzerland, The Netherlands, Turkey and United Arad Emirates.
Affected count
3,085,080
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
15 L Cycler Drainage Bag Product Usage: For use with Baxter Cycler Tubing sets as a peritoneal dialysis accessory.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0080-2015Don't want to check this manually?
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