Reported Nov 22, 2023 · Ongoing
Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N DRAIN, EXPRESS, BRU
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?
- Express Dry Seal Chest Drains (Express)4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N DRAIN, EXPRESS, BRU
- Lot codes and dates
- UDI-DI
(1)4000-100N DRAINEXPRESSSINGLE 20650862115134(2) 4050-100N DRAINEXPRESSBRU 20650862115141 All lots within labeled
- product expiry Manufacturing DatesAny product manufactured on and after July 21, 2020
- Distribution Dates
Any product shipped on and after August 62020
- UDI-DI
- Amount recalled
- 48339 cases: 48148 cases US; 193 cases 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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