Ocean Water Seal Chest Drain Recalled for Inadequate Setup Instructions
Atrium Medical is recalling 87,972 Ocean Water Seal Chest Drains due to inadequate setup instructions that may result in treatment delays and risk of patient harm.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall for inadequate setup instructions that could result in treatment delays and patient harm. No illnesses or injuries have been reported, limiting the score to High per the rubric.
Plain-English summary
The Ocean Water Seal Chest Drain is a plastic, three-bottle vacuum collection device used in medical procedures to collect blood and fluid while preventing air from entering the pleural space. The device is manufactured by Atrium Medical Corporation.
The FDA has initiated this Class II recall due to inadequate or inappropriate setup instructions. These flawed instructions may result in treatment delays and create an unreasonable risk of harm to patients.
Approximately 87,972 chest drains (14,662 cases) were distributed nationwide in the United States and internationally to countries including Canada, Mexico, and the United Kingdom. Multiple lot codes are affected; patients and healthcare providers should verify their device's lot number against the recall information provided by the FDA or manufacturer.
Healthcare providers and patients who have this device should carefully review the setup instructions and contact Atrium Medical Corporation with any questions regarding proper setup and use.
The recalled product
- Product
- The Ocean Water Seal Chest Drain is a plastic, three bottle vacuum collection device. It consists of a collection chamber that holds shed mediastinal blood, a water seal chamber using a water seal that prevents air from entering into the pleural space and a suction control…
- Manufacturer
- Atrium Medical Corporation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Product Code/REF Number 2002-400
- Lot codes: 441533
- 443300
- 443608
- 443629
- 444473
- 445527
- 448966
- 449683
- 450899
- 450900
- 451270
- 451988
- 452177
- 452814
- 454577
- 455871
- 458264
- 458604
- 459198
Distribution
Distributed nationwide across the United States.
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