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U.S. Department of Health and Human Services

Class 2 Device Recall Maquet Inc.

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  Class 2 Device Recall Maquet Inc. see related information
Date Initiated by Firm February 16, 2017
Date Posted March 23, 2017
Recall Status1 Terminated 3 on March 21, 2019
Recall Number Z-1769-2017
Recall Event ID 76518
510(K)Number K080592  
Product Classification Tubing, pump, cardiopulmonary bypass - Product Code DWE
Product Custom Tubing Pack with Bioline Coating
UDI code: 00607567208230
Part Number: 709000058

The HLM Tubing Sets with Bioline Coating are for single use only. They may be sold sterile, non-sterile, and bulk packed. Custom tubing sets that are sold sterile are not to be re-sterilized by the user. In open heart surgery the HLM Tubing Sets with Bioline Coating are used in combination with the heart-lung machine for the oxygenation of blood and removal of carbon dioxide. The main purpose of the HLM Tubing Sets with Bioline Coating is to connect the patient to the heart-lung machine and its components. The HLM Tubing Sets with Bioline Coating are therefore a component in the extracorporeal perfusion circulation system. The utilization period of the use of the tubing sets is restricted to six hours. The Bioline Coating improves the physical surface properties of products for the extracorporeal circulation system.
Code Information Lot number 3000033848
Recalling Firm/
Manufacturer		 Datascope Corporation
15 Law Dr
Fairfield NJ 07004-3206
For Additional Information Contact
973-709-7442
Manufacturer Reason
for Recall		 A complaint was received on January 1, 2017 stating the pigtail on line 2 of the oxygenator was assembled to the port where the yellow cap and the clear cap remained on the center port.
FDA Determined
Cause 2		 Device Design
Action Maquet Inc. was notified by their customer on January 1, 2017. This was a reverse notification. The one impacted customer said they will not return the product since they can easily correct the pigtail connection before use. For further questions regarding this recall, please call (973) 709-7442.
Quantity in Commerce 21 kits
Distribution US Distribution to the state of : CA.
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 = DWE and Original Applicant = MAQUET CARDIOPULMONARY AG
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