Reported Nov 22, 2023 · Ongoing
Oasis Dry Suction Water Seal Chest Drains (Oasis): (1)3600-100 DRAIN, OASIS SINGLE W/AC; (2)3612-100 DRAIN, OASIS PEDI…
Atrium Medical Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Atrium Medical Corporation · 40 Continental Blvd · Merrimack, NH · 03054-4332
Is this the product you have?
- Oasis Dry
- Suction Water Seal Chest Drains (Oasis)(1)3600-100 DRAIN, OASIS SINGLE W/AC; (2)3612-100 DRAIN, OASIS PEDI A/C; (3)3650-100 DRAIN, OASIS BRU W/AC
- Lot codes and dates
3 of 3 products
Products covered by this recall # Barcodes Product as published 1 20650862110016(1)3600-100 DRAIN, OASIS SINGLE W/AC 20650862110016 2 20650862111013(2)3612-100 DRAIN, OASIS PEDI A/C 20650862111013 3 20650862113017(3) 3650-100 DRAIN, OASIS BRU W/AC 20650862113017 All lots within labeled product expiry Manufacturing Dates: Any product manufactured on and after July 21, 2020 Distribution Dates: Any product shipped on and after August 6, 2020 - Amount recalled
- 471037 cases US; 638 case OUS
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
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 tube connections with single collection chamber chest drains
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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