Recall Z-0779-2019 ยท CAC Apparatus, Autotransfusion
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.
| Date | Aug 2, 2017 |
| Status | Terminated |
| 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 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101907 | HAEMONETICS CELL SAVER ELITE AUTOTRANSFUSION SYSTEM Haemonetics Corp., Dec 3, 2010 |