Recall Z-0778-2019— Haemonetics Corporation
Class II · Terminated
Class II FDA medical device recall by Haemonetics Corporation, initiated 2017-08-02, terminated 2020-08-06. It names one FDA 510(k) clearance: K014083. 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.. Reason: Haemonetics has received isolated reports that in some cases the 70ml centrifuge bowl may leak during cell salvage processing..
- Recalling firm
- Haemonetics Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-08-02
- Terminated
- 2020-08-06
- Firm location
- Braintree, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.