FDAFDA · Food and drugs·Recall number Z-0779-2019
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.
Published February 6, 2019 · Recall initiated: August 2, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Haemonetics has received isolated reports that in some cases the 70ml centrifuge bowl may leak during cell salvage processing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Haemonetics Corporation
- Distributor
- 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.
- Lot
- Catalog number: CSE-P-70
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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