Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N DRAIN, EXPRESS, BRU
Reported: November 22, 2023 Initiated: September 18, 2023 #Z-0318-2024
Product Description
Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N DRAIN, EXPRESS, BRU
Reason for Recall
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
Details
- Recalling Firm
- Atrium Medical Corporation
- Units Affected
- 48339 cases: 48148 cases US; 193 cases OUS
- Distribution
- Worldwide distribution - US Nationwide and the countries of Algeria, Australia, Austria, Bahrain, Belgium, Brazil, Brunei Darussalam, Canada, Chile, China, Czech Republic Ecuador, Egypt, Finland, France, Germany, Hong Kong, Iceland, Indonesia, Ireland, Israel, Italy, Jordan, Korea, Republic of Kuwait, Latvia, Lithuania, Luxembourg, Malaysia, Malta, Mauritius, Mexico, Montenegro, Netherlands, New Zealand, Norway, Pakistan, Peru, Poland, Portugal, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan Province of China, Thailand Tunisia, Ukraine, United Arab Emirates, United Kingdom, Uruguay.
- Location
- Merrimack, NH
Frequently Asked Questions
What product was recalled? ▼
Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N DRAIN, EXPRESS, BRU. Recalled by Atrium Medical Corporation. Units affected: 48339 cases: 48148 cases US; 193 cases OUS.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 22, 2023. Severity: Moderate. Recall number: Z-0318-2024.
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