Device product
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.
Z-0778-2019
Product summary
- Event
- Event 79031
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11,208 units
- Official record key
device-enforcement:Z-0778-2019
Official wording
Reason: Haemonetics has received isolated reports that in some cases the 70ml centrifuge bowl may leak during cell salvage processing.
Code information: Catalog number: 0291A-00, 0291E-00
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.
Derived failure modes
-
Unknown
Haemonetics has received isolated reports that in some cases the 70ml centrifuge bowl may leak during cell salvage processing.