FDA Medical Device Recalls (openFDA)
Haemonetics Corporation: 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.
- Recall number
- Z-0779-2019
- Recalling firm
- Haemonetics Corporation
- Product
- 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.
- Status
- Terminated
- Initiated
- 2017-08-02
- Posted
- not on file
- Terminated
- 2020-08-06
- Reason
- Haemonetics has received isolated reports that in some cases the 70ml centrifuge bowl may leak during cell salvage processing.
- Root cause
- Process control
- Action
- On August 2, 2017, the firm, Haemonetics, sent a customer notification letter titled "URGENT Medical Device Recall for 70ml Centrifuge Bowls" to all customers. The letter informs the customers of the risk to health, actions to be taken and the product and distribution information. Action to be Taken by Customer: Please discontinue use of the products listed in the letter and return any unused product to Haemonetics. Contact your local customer service representative at 800-537-2802 to coordinate the return, shipment and credit receipt of unused product. Customers were also instructed to complete and return the RECALL ACKNOWLEDGEMENT FORM BY FAX TO +1-781-356-3558 OR SCAN AND E-MAIL TO CORPORATEREGULATORY@HAEMONETICS.COM. Customers with questions or concerns are instructed to call the Customer Support Team at 800-537-2802 or email at customerservicena@haemonetics.com.
- Quantity
- 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.
- Lot, serial or model codes
- Catalog number: CSE-P-70
- 510(k) numbers
- ["K101907"]
- PMA numbers
- not on file
- Product code
- CAC
- Firm FEI
- 1219343
- Firm city
- Braintree
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28