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U.S. Department of Health and Human Services

Class 1 Device Recall Atrium Express Dry Suction Dry Seal Chest Drain

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  Class 1 Device Recall Atrium Express Dry Suction Dry Seal Chest Drain see related information
Date Initiated by Firm December 13, 2023
Date Posted January 12, 2024
Recall Status1 Open3, Classified
Recall Number Z-0710-2024
Recall Event ID 93548
510(K)Number K201305  
Product Classification Apparatus, autotransfusion - Product Code CAC
Product Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit
Code Information UDI-DI 00650862115147 Lots 499345 498062 496693 495731 494226 492645 492078 490763 487811 490139 489162 487849 483249 470644 468860 467477 466952
Recalling Firm/
Manufacturer		 Maquet Cardiovascular, LLC
45 Barbour Pond Dr
Wayne NJ 07470-2094
Manufacturer Reason
for Recall		 Express chest drains are pre-packaged with sterile water syringes which have bene recalled. If the device is not kept in an upright position, the patient may be exposed to infectious material. Subsequent hazards include but are not limited to infection, abscess, sepsis, and death.
FDA Determined
Cause 2		 Material/Component Contamination
Action On December 13, 2023, the firm notified customers through "URGENT MEDICAL DEVICE CORRECTION" letters. Customers were instructed to examine their inventory to determine if they had any affected lots of the Atrium Express Dry Suction Dry Seal Chest Drains. The correction only affects the sterile water syringe; do not use this syringe. If customers do not need visualization of active pneumothorax, they may keep the affected Express chest drain and set up without water. If customers wish to use the Express chest drain as intended, they may replace the affected sterile water syringe with a new syringe filled with sterile water using aseptic technique. Customers also have the option of returning affected Express chest drains to the firm for credit. If you have any questions, please contact your Getinge representative or call the Getinge Customer Support at (888) 943-8872 (press option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m.(Eastern Time Zone).
Quantity in Commerce (7,501 cases/45,006 devices US); no OUS
Distribution Worldwide distribution: US (nationwide) and OUS (Foreign) to countries of: Australia, Brazil, Canada, Luxembourg, Netherlands, Norway, Spain and UK
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = CAC and Original Applicant = Atrium Medical Corporation
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