—#196582

Product

Atrium Ocean Wet Suction Water Seal Chest Drain- Product Code: 2002-000

FDA product code: KDQ — Bottle, Collection, Vacuum
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K043582
Affected lot / code info: UDI-DI: 20650862100017 - case / 00650862100013- each Lot Number: 472326, 473226

Why it was recalled

Warehouse experienced temperature excursions in July and August 2021. It was determined that there were no associated harms to patients.

Root cause (FDA determination)

Storage

Action the firm took

Atrium/ Getinge issued Urgent Medical Device Removal on 10/18/21 via email with Delivery and Read receipt. Letter states reason for recall, health risk and action to take: Our records indicate that McKesson has received the Atrium Ocean Wet Suction Water Seal Chest Drains from the lot listed on Page 1. " Please examine your inventory and confirm that you have no remaining Atrium Ocean Wet Suction Water Seal Chest Drain 2002-000 with the REF/LOT number listed in this notice. Please return any product that may be affected under this Field Action. " Please respond to this email using the response form on page 3 to acknowledge that you have received this notification. If you have any questions, please contact your Atrium/Getinge representative or call the Atrium/Getinge Customer Support at (603) 880-1433 (press option 1), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).

Recalling firm

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

Distribution

Distribution pattern: US Nationwide distribution in the state of VA.

Timeline

Recall initiated: 2022-10-18
Posted by FDA: 2022-11-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #196582. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.