Public recall detail

Atrium Ocean, Oasis, and Express Chest Drains

2023-09-29

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Recall Safety notice
Quick summary

Quick summary: Atrium Ocean, Oasis, and Express Chest Drains . Date: 2023-09-29.

Recommended action

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

Recall details

Quick summary: Atrium Ocean, Oasis, and Express Chest Drains . Date: 2023-09-29.

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
ProductAtrium Ocean, Oasis, and Express Chest Drains
IssueMedical devices - Labelling and packaging
Recall classType II
IdentificationRA-74345

Affected products

ProductOcean Chest Drain
LotAll lots.
Model2002-100 2002-300 2002-000 2012-320
Serial numberAll lots.
DescriptionOcean Chest Drain
ProductOasis Chest Drain
LotAll lots.
Model3650-100 3600-100 3612-100
Serial numberAll lots.
DescriptionOasis Chest Drain
ProductExpress Chest Drain
LotAll lots.
Model4000-100N
Serial numberAll lots.
DescriptionExpress Chest Drain

Issue

The instructions for use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient line connections with single collection chamber chest drains. Recall Start Date: September 21, 2023

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - General and plastic surgery
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-74345
Background{}
CompaniesAtrium Medical Corporation 40 Continental Blvd., Merrimack, New Hampshire, United States, 03054
AudiencesHealthcare
Source updated2023-09-29

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

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