Haemonetics Corporation recalls Cell Saver 5/5+ Bowl Set, 70ml, Product ID: 0291E-00, 0291A-00 Indications for Use: The Haemonetics Cell Saver 5/5+ Sys…

Recall date

August 2, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0778-2019

FDA classification

Class II

Brand / firm

Haemonetics Corporation

Sold / distributed

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.

Why it was recalled

Haemonetics has received isolated reports that in some cases the 70ml centrifuge bowl may leak during cell salvage processing.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.