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Class 2 Device Recall ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION |
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Date Initiated by Firm |
April 29, 2011 |
Date Posted |
June 07, 2011 |
Recall Status1 |
Terminated 3 on April 21, 2014 |
Recall Number |
Z-2420-2011 |
Recall Event ID |
58658 |
510(K)Number |
K992723
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Product Classification |
Apparatus, autotransfusion - Product Code CAC
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Product |
Haemonetics OrthoPAT -Orthopedic Perioperative Autotransfusion System US Only: 1050-110-ENG Outside US: 1050-110-ENG, I050-240-XXX (generic), 1050-240-ENG, 1050-240-SPN, 1050-240-ITL, 1050-240GER, 1050-240-DUT, 1050-240-FRN, 1050-240-CZE, 1050-IIO-JPN.
Provides perioperative autotransfusion ( salvaging and reinfusing red blood cells (RBC's) from blood shed from patients undergoing orthopedic surgery. The portable system is used in operating rooms to recycle blood lost during surgery and in the recovery room to recycle blood lost after surgery. It can be transported to the patient floor for postoperative salvage. |
Code Information |
Model 1: No Spill Collection System Serial numbers 00001 through 02279-T Model 2: Serial numbers beginning with 02280-T |
Recalling Firm/ Manufacturer |
Haemonetics Corporation 400 Wood Rd Braintree MA 02184-2412
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For Additional Information Contact |
781-848-7100
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Manufacturer Reason for Recall |
2 Models
Model 1:
OrthoPAT devices with no centrifuge drain spill containment system may have potential for fluid contamination leading to potential spark or smoke may occur are recalled
Model 2:
OrthoPat equipped with a spill collection drainage system updated with revised Instructions for Use and Quick reference Guide Addendum
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FDA Determined Cause 2 |
Device Design |
Action |
The firm, Haemonetics, sent an "Urgent Field Recall" letter dated April 29, 2011 to all customers. The letter describes the product, problem and actions to be taken. This recall covers the 2 models. Model 1: OrthoPAT devices without drain ports (Serial numbers 00001 through 02279-T). All OrthoPAT devices without drain ports worldwide, will be removed from distribution and scrapped.
Model 2: OrthoPAT devices with drain ports (serial numbers beginning with 02280-T and higher). All OrthoPAT devices with drain ports will remain in clinical use and will receive updated labeling.
The customers were instructed to follow the enclosed directions to confirm their possession of any units of this model and arrange for their return to Stericycle; immediately cease use of devices not equipped with a spill collection drainage system ( to determine whether their OrthoPAT device is equipped with the spill collection drainage system, please refer to the attached illustrations/instructions); complete and return the IMPORTANT-CUSTOMER CONFIRMATION sheet via fax to: Stericycle at 1-866-792-5450, and RETURN the OrthoPAT devices NOT equipped with spill collection drainage system (for instructions on how to arrange return of OrthoPAT Devices, call a Stericycle Representative at 1-866-918-8736). A Haemonetics representative will be in contact with the customers facility within 14 working days to assist with the recall actions.
The firm, Haemonetics, will update the OrthoPAT labeling. The labeling will have specific instructions to permanently deploy the centrifuge spill collection bag at all times. Device cleaning instructions in the event of a blood spill are also clarified and include specific instructions to unplug the device from the AC outlet in the event of a fluid spill on the device. If a device does experience a fluid spill, new instructions direct the user to return the device to Haemonetics for evaluation and repair. Operator Manuals will be replaced with a new revisi |
Quantity in Commerce |
2976 units |
Distribution |
Worldwide distribution: USA (nationwide) and countries including: Austria, Australia, Belgium, Switzerland, Canada, China, Czech Republic, Germany, Spain, Finland, France, Great Britain, Greece, Guatemala, Ireland, Israel, India, Italy, Japan, Lithuania, Luxembourg, Latvia, Monaco, Netherlands, Norway, Panama, Poland, Puerto Rico, Russian Federation, Saudi Arabia, Singapore, Slovak Republic, EI Salvador, Turkey and Taiwan., |
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 and Original Applicant = TRANSFUSION TECHNOLOGIES CORP.
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