FDA Enforcement
Class II
Terminated
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.
Recall: Z-0778-2019
·
Reported February 6, 2019
Enforcement
- Recall Number
- Z-0778-2019
- Event ID
- 79031
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Haemonetics Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 6, 2019
- Initiation Date
- August 2, 2017
- Classification Date
- January 28, 2019
- Termination Date
- August 6, 2020
- Address
- 400 Wood Rd, N/A, Braintree, MA, 02184-2412, United States
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
Haemonetics has received isolated reports that in some cases the 70ml centrifuge bowl may leak during cell salvage processing.
Code Info
Catalog number: 0291A-00, 0291E-00
Distribution
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.
Quantity
11,208 units