—#198706

Product

Atrium Pneumostat Chest Drain Valve, Part Number 16100

FDA product code: KDQ — Bottle, Collection, Vacuum
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: 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

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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

Recalling firm

Firm: Atrium Medical Corporation
Address: 40 Continental Blvd, Merrimack, New Hampshire 03054-4332

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2023-03-01
Posted by FDA: 2023-03-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #198706. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.