Z-0778-2019 Class II Terminated
FDA device recall Z-0778-2019 was initiated by Haemonetics Corporation on August 2, 2017 and is designated Class II. Reason for recall: Haemonetics has received isolated reports that in some cases the 70ml centrifuge bowl may leak during cell salvage processing. The recall status is terminated (terminated August 6, 2020). Affected quantity: 11,208 units.
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