Recall Z-0779-2019
Haemonetics Corporation · initiated August 2, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Catalog number: CSE-P-70
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: 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.
Details
- Recall number
- Z-0779-2019
- Initiated
- August 2, 2017
- Terminated
- August 6, 2020
- Product code
- CAC – Apparatus, Autotransfusion
- 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.
- Recalling firm
- Haemonetics Corporation, Braintree, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0778-2019 Class II | Cell Saver 5/5+ Bowl Set, 70ml, Product ID: 0291E-00, 0291A-00 Indications for Use: The…Haemonetics has received isolated reports that in some cases the 70ml centrifuge bowl may leak during cell… | 08/02/2017Terminated |