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U.S. Department of Health and Human Services

Class 2 Device Recall Haemonetics OrthoPat

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  Class 2 Device Recall Haemonetics OrthoPat see related information
Date Initiated by Firm July 13, 2018
Create Date August 30, 2018
Recall Status1 Terminated 3 on June 16, 2020
Recall Number Z-2951-2018
Recall Event ID 80740
510(K)Number K122262  
Product Classification Apparatus, autotransfusion - Product Code CAC
Product Haemonetics¿ OrthoPAT¿ System-OPAT QuickConnect Reservoirs.
Product Code: OPT-R-1000

The OrthoPAT orthopedic perioperative autotransfusion system indicated for use to salvage RBCs from blood lost intraoperatively and postoperatively during surgical procedures

Code Information Lot # 1117066
Recalling Firm/
Haemonetics Corporation
400 Wood Rd
Braintree MA 02184-2412
For Additional Information Contact SAME
Manufacturer Reason
for Recall
OrthoPAT¿ reservoirs are missing the cannula inside the reservoirs. The absence of this cannula prevents the emptying of blood from the reservoirs. The inability to empty the reservoir means that the collected blood cannot be processed.
FDA Determined
Cause 2
Process control
Action The firm, Haemonetics, notified customers by an email titled "URGENT: MEDICAL DEVICE RECALL" on July 13, 2018 . The email described the product, problem, and actions to be taken. The customers were instructed to inspect product for defect and return units of the affected lots for replacement with non-affected units; complete the attached customer acknowledgement form via FAX TO +1-781-356-3558 OR SCAN AND E-MAIL TO: CORPORATEREGULATORY@HAEMONETICS.COM. You can contact your local customer service representative at: North America 1.800.537.2802 or email:customerservicena@haemonetics.com.
Quantity in Commerce 348 units
Distribution US Nationwide Distribution
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.