| Class 2 Device Recall Autotransfusion Apparatus | |
Date Initiated by Firm | August 02, 2017 |
Create Date | January 28, 2019 |
Recall Status1 |
Terminated 3 on August 06, 2020 |
Recall Number | Z-0779-2019 |
Recall Event ID |
79031 |
510(K)Number | K101907 |
Product Classification |
Apparatus, autotransfusion - Product Code CAC
|
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. |
Code Information |
Catalog number: CSE-P-70 |
Recalling Firm/ Manufacturer |
Haemonetics Corporation 400 Wood Rd Braintree MA 02184-2412
|
For Additional Information Contact | Ian Purdy 800-537-2802 |
Manufacturer Reason for Recall | Haemonetics has received isolated reports that in some cases the 70ml centrifuge bowl may leak during cell salvage processing. |
FDA Determined Cause 2 | 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 in Commerce | 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. |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database | 510(K)s with Product Code = CAC
|
|
|
|