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.
This recall has been terminated (originally issued August 2, 2017).
- Company
- Haemonetics Corporation
- Recall Initiated
- August 2, 2017
- Terminated
- August 6, 2020
- Recall Number
- Z-0778-2019
- Quantity
- 11,208 units
- Firm Location
- Braintree, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Haemonetics has received isolated reports that in some cases the 70ml centrifuge bowl may leak during cell salvage processing.
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 / Code Info
Catalog number: 0291A-00, 0291E-00
Root Cause
Process control
Action Taken
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.