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.
Reported: February 6, 2019 Initiated: August 2, 2017 #Z-0779-2019
Product Description
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.
Reason for Recall
Haemonetics has received isolated reports that in some cases the 70ml centrifuge bowl may leak during cell salvage processing.
Details
- Recalling Firm
- Haemonetics Corporation
- Units Affected
- 4576 units
- 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.
- Location
- Braintree, MA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Haemonetics Corporation. Units affected: 4576 units.
Why was this product recalled? ▼
Haemonetics has received isolated reports that in some cases the 70ml centrifuge bowl may leak during cell salvage processing.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 6, 2019. Severity: Moderate. Recall number: Z-0779-2019.
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