Public recall detail

Express Mini 500 and Pneumostat Chest Drain Valve

2023-03-15

medium
Recall Safety notice
Quick summary

Quick summary: Express Mini 500 and Pneumostat Chest Drain Valve. Date: 2023-03-15.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Express Mini 500 and Pneumostat Chest Drain Valve. Date: 2023-03-15.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandATRIUM MEDICAL CORPORATION
ProductExpress Mini 500 and Pneumostat Chest Drain Valve
IssueMedical devices - Labelling and packaging
Recall classType II
IdentificationRA-73332

Affected products

ProductExpress Mini 500
LotAll lots.
Model16400
Serial numberAll lots.
DescriptionExpress Mini 500
ProductPneumostat Chest Drain Valve
LotAll lots.
Model16100
Serial numberAll lots.
DescriptionPneumostat Chest Drain Valve

Issue

The instructions for use (IFU) for the Pneumostat Chest Drain Valve and for the Express Mini 500 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. The notices for this recall give the appropriate precautions to the end users. Recall start date: March 6, 2023

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceIndustry
CategoryHealth products - Medical devices - General hospital and personal use
CompaniesAtrium Medical Corporation 40 Continental Blvd., Merrimack, New Hampshire, United States, 03054
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-73332
Background{}
CompaniesAtrium Medical Corporation 40 Continental Blvd., Merrimack, New Hampshire, United States, 03054
AudiencesIndustry
Source updated2023-03-15

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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