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Class 2 Device Recall Pneumostat Chest Drain Valve |
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Date Initiated by Firm |
March 01, 2023 |
Date Posted |
March 30, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1302-2023 |
Recall Event ID |
91718 |
Product Classification |
Bottle, collection, vacuum - Product Code KDQ
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Product |
Atrium Pneumostat Chest Drain Valve, Part Number 16100 |
Code Information |
UDI-DI: 20650862161001;
All lots manufactured 3 years prior to correction initiation:
Lot Numbers: 453404
455900
458299
464069
455901
454344
448618
449703
449992
449993
450923
450924
451439
452012
452013
452575
453404
453472
454260
454344
454345
454589
454803
454850
454851
455359
455360
455370
455898
455900
455901
456447
456448
456904
456905
458298
458299
458300
458301
458642
458643
458644
458645
461545
463439
463441
463442
463443
463469
463586
463587
464069
464103
464104
464105
464669
464809
465368
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Recalling Firm/ Manufacturer |
Atrium Medical Corporation 40 Continental Blvd Merrimack NH 03054-4332
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For Additional Information Contact |
Maryanna Krivak 973-709-7483
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Manufacturer Reason for Recall |
The Instructions for Use (IFU) for the Pneumostat Chest Drain Valve and the Express Mini 500 Dry Seal Chest Drains do not provide sufficient precaution against draining the device for continued use. Additionally, the IFUs do not provide sufficient precaution or warning against the use of the device outside the healthcare setting.
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FDA Determined Cause 2 |
Under Investigation by firm |
Action |
Urgent Medical Device Correction letters dated 3/1/23 were sent to customers.
Updated Instructions New Warning and Precautions:
The facility can continue use of the product with the IFU that was provided along with the consideration of the following:
" NEW and Applicable Existing Warnings and Precautions for Express Mini 500:
o NEW Warning: The Express Mini 500 is restricted for use by trained healthcare providers familiar with cardiothoracic surgical procedures and techniques, including the use of chest drains.
o NEW Precaution: The Express Mini 500 is restricted for use in a healthcare facility. The Express Mini 500 should not be used for outpatient drainage.
o NEW Precaution: Use of the Luer port is intended only for sampling patient drainage. Do not use the Luer port or any other means to empty fluid from the collection chamber.
o Existing Precaution: Replace chest drain if damaged or when collection volume meets or exceeds maximum capacity.
Actions to be Taken by the Customer:
" Please ensure that all Atrium Express Mini 500 Dry Seal Chest Drain users at your facility are aware of this Safety Notice and post a copy of the Notice on Page 3 in all inventory locations within your facility where the devices are stored. Your facility can continue use of the device. No devices need to be returned.
" Please forward this information to all current and potential Atrium Express Mini 500 Dry Seal Chest Drain users
within your hospital / facility.
" If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action.
" Please complete and sign the attached URGENT: MEDICAL DEVICE CORRECTION - RESPONSE FORM on Page 4 to acknowledge that you have received this notification. Return the completed form to Atrium/Getinge by emailing a scanned copy of the completed form to Mini500-Pneumostat-2023.Atrium@getinge.com or or by faxing the form to (866)-308-8040.
Type of Action Taken by Getinge:
Atrium |
Quantity in Commerce |
3554 cases of 10 |
Distribution |
Worldwide distribution - US Nationwide and the countries of United Arab Emirates, Austria, Australia, Belgium, Brazil, Canada, Switzerland, Colombia, Czech Republic, Germany, Ecuador, Estonia, Spain, Finland, France, United Kingdom, Hong Kong, Indonesia, Ireland, Israel, Iceland, Italy, Jordan, South Korea, Kuwait, Luxembourg, Mexico, Malaysia, Netherlands, Norway, New Zealand, Peru, Philippines, Poland, Portugal, Sweden, Singapore, Slovenia, Thailand. |
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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