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U.S. Department of Health and Human Services

Class 2 Device Recall Atrium Pneumostat Chest Drain Valve

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  Class 2 Device Recall Atrium Pneumostat Chest Drain Valve see related information
Date Initiated by Firm August 26, 2021
Create Date September 29, 2021
Recall Status1 Open3, Classified
Recall Number Z-2592-2021
Recall Event ID 88446
510(K)Number K984496  
Product Classification Bottle, collection, vacuum - Product Code KDQ
Product Atrium Pneumostat Chest Drain Valve, Part Number 16100
Code Information Lots 433297 433298 433974 433692 433693 434040 434962 435699 432585 435659 435660 436107 436106 437111 437530 438520 439396 439891 439905 440201 441182 441183 441392 441184 441185 441553 441554 443330 443362 443849 443968 445021 446022 447065 448203 447066 448138 448139 448618 448995 448996 450275 449702 449703 449992 449993 450659 450467 450923 450924 451439 452012 452013 453085 453472 452575 453404 454260 454344 454345 454803 454589 454850 455370 454851 455360 455359 455898 455900 455901 456447 456448 456904 456905 458298 458300 458299 458301 458642 458643 458644 458645 459216 461545 463439 463441 463469 463442 463443 463586 463587 464069 464103 464809 464104 464105 464669 465368 
Recalling Firm/
Manufacturer		 Atrium Medical Corporation
40 Continental Blvd
Merrimack NH 03054-4332
For Additional Information Contact Maryanna Krivak
973-709-7483
Manufacturer Reason
for Recall		 The firm is revising the Indication for Use, Contraindications, Warnings, and Precautions, after the device was involved in the treatment of a preterm infant who later died.
FDA Determined
Cause 2		 Under Investigation by firm
Action On August 26, 2021, the firm issued Urgent Medical Device Correction letters to affected customers. Customers were informed that Atrium/Getinge is in the process of updating the Instructions for Use. In the meantime, the following information was provided: REVISED Indication for Use: Pneumostat is indicated for use with adult patients in a variety of medical conditions in which evacuation of air with or without ancillary fluid is required from the pleural cavity and is also designed to facilitate ambulation. These medical conditions may include pneumothorax, thoracic injury, and other related conditions requiring air evacuation. NEW Contraindication: Not for use in pediatric patients. NEW section for Target Population: The Pneumostat is intended for adult patients who require gravity drainage. NEW Warning: Do not use in situations that require active negative pressure in the pleural space. NEW Precaution: The use of the Pneumostat is restricted to the clinical setting. NEW Precaution: The use of the Pneumostat is restricted to professional healthcare users familiar with thoracic surgical procedures and techniques, including the use of thoracic chest drains. Actions to be taken by Customer: - Please examine your inventory immediately to determine if you have any of the Atrium Pneumostat Chest Drain Valves with the product code 16100. - Please ensure that all Pneumostat Chest Drain Valve users at your facility are aware of this notice and post a copy of the Warning Label included with the letter in all inventory locations within your facility where the Atrium Pneumostat Chest Drain Valves are stored. If you have any questions, please contact your Atrium/Getinge representative or call the Atrium/Getinge Customer Support at (603) 880-1433 (press option 1), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).
Quantity in Commerce 92,430 units
Distribution Domestic distribution nationwide. Foreign distribution worldwide.
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 = KDQ and Original Applicant = ATRIUM MEDICAL CORP.
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