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U.S. Department of Health and Human Services

Class 2 Device Recall Express Mini 500 Dry Seal Chest Drain

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 Class 2 Device Recall Express Mini 500 Dry Seal Chest Drainsee related information
Date Initiated by FirmMarch 01, 2023
Date PostedMarch 30, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1303-2023
Recall Event ID 91718
Product Classification Bottle, collection, vacuum - Product Code KDQ
ProductExpress Mini 500 Dry Seal Chest Drain, Part Number 16400
Code Information UDI-DI: 00650862164008; All lots manufactured 3 years prior to correction initiation: Lot Numbers: 477059 478375 481999 483536 484044 485782 486195 477059 478375 481105 485782 449700 450921 451436 460632 463584 463585 464668 472965 472969 473749 477059 445024 448992 449700 449990 450921 450922 451436 452010 452011 452574 453402 460620 460621 460629 460630 460631 460632 460633 460787 461043 461333 461336 461337 461821 461822 461823 461824 461940 462215 462487 462489 463584 463585 464101 464102 464667 464668 465132 465138 465516 465517 465667 465668 472838 472965 472966 472969 473749 475492 477059 477985 475492 477059 478375 481105 481998 482573 485782 486195 486195 474692 475492 477059 478375 480643 481104 481105 481998 481999 482001 482572 482573 483028 483536 484044 485782 486195 487568 487569 487570 488316 489338 489879 489880 490140 486195 487570 490140 472838 472965 472966 472968 472969 473221 473749 474692 475491 475492 477059 477926 477983 477984 477985 478374 479256 479870 480216 480217 480641 480642 480643
FEI Number 3011175548
Recalling Firm/
Manufacturer		 Atrium Medical Corporation
40 Continental Blvd
Merrimack NH 03054-4332
For Additional Information ContactMaryanna Krivak
973-709-7483
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.
FDA Determined
Cause 2		Under Investigation by firm
ActionUrgent 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 Commerce8184 cases of 6
DistributionWorldwide 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 CycleTPLC 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.
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