Date Initiated by Firm | July 13, 2018 |
Create Date | August 30, 2018 |
Recall Status1 |
Terminated 3 on June 16, 2020 |
Recall Number | Z-2950-2018 |
Recall Event ID |
80740 |
510(K)Number | K992723 |
Product Classification |
Apparatus, autotransfusion - Product Code CAC
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Product | Haemonetics OrthoPAT System-Integrated Set.
Product Code: 1150H-00
OrthoPAT orthopedic perioperative autotransfusion system indicated for use to salvage RBCs from blood lost intraoperatively and postoperatively during surgical procedures |
Code Information |
Lot # 1017049 , 1150H-00, 1017072 |
Recalling Firm/ Manufacturer |
Haemonetics Corporation 400 Wood Rd Braintree MA 02184-2412
|
For Additional Information Contact | SAME 781-848-7100 |
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 | 432 units |
Distribution | US Nationwide Distribution |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = CAC
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