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Haemonetics Corporation recalls Cell Saver Elite Processing Kit, 70 ml, Product ID: CSE-P-70 Indications for Use: The Haemonetics Cell Saver 5/5+ Sys
Recalled February 6, 2019 · FDA recall Z-0779-2019 · Haemonetics
Hazard
Haemonetics has received isolated reports that in some cases the 70ml centrifuge bowl may leak during cell salvage processing. · FDA Class II
Units
4576 units
Sold at
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.
Description
Haemonetics has received isolated reports that in some cases the 70ml centrifuge bowl may leak during cell salvage processing.
Product
Cell Saver Elite Processing Kit, 70 ml, Product ID: CSE-P-70 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.
Manufacturer(s)
Haemonetics Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →