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U.S. Department of Health and Human Services

Class 2 Device Recall Autotransfusion Apparatus

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  Class 2 Device Recall Autotransfusion Apparatus see related information
Date Initiated by Firm August 02, 2017
Create Date January 28, 2019
Recall Status1 Terminated 3 on August 06, 2020
Recall Number Z-0778-2019
Recall Event ID 79031
510(K)Number K014083  
Product Classification Apparatus, autotransfusion - Product Code CAC
Product 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.
Code Information Catalog number: 0291A-00, 0291E-00
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 11,208 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 and Original Applicant = HAEMONETICS CORP.
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