Home / Recalls / Haemonetics Corporation / Z-0778-2019

Z-0778-2019 Class II Terminated

Recalled by Haemonetics Corporation — Braintree, MA

Recall Details

Product Type
Devices
Report Date
February 6, 2019
Initiation Date
August 2, 2017
Termination Date
August 6, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
11,208 units

Product Description

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.

Reason for Recall

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

Distribution Pattern

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.

Code Information

Catalog number: 0291A-00, 0291E-00

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