FDA-Device2019-02-06Class II
Cell Saver 5/5+ Bowl Set, 70ml, Product ID: 0291E-00, 0291A-00 Indications for Use: The Haemonetics Cell Saver 5/5+ System and its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.
Haemonetics Corporation
Hazard
Haemonetics has received isolated reports that in some cases the 70ml centrifuge bowl may leak during cell salvage processing.
Sold states
US Nationwide Distribution to states of: AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, LA, MA, MD, ME, MN, MO, NC, NE, NH, NJ, NY, OH, OR, PA, SC, TN, TX, VA, WA, and WI.
Affected count
11,208 units
Manufactured in
400 Wood Rd, N/A, Braintree, MA, United States
Products
Cell Saver 5/5+ Bowl Set, 70ml, Product ID: 0291E-00, 0291A-00 Indications for Use: The Haemonetics Cell Saver 5/5+ System and its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0778-2019Don't want to check this manually?
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