The Ocean Water Seal Chest Drain is a plastic recall
The Ocean Water Seal Chest Drain is a plastic, three bottle vacuum collection device. It consists of a collection chamber that holds shed mediastinal…
Why was The Ocean Water Seal Chest Drain is a plastic recalled?
Inadequate/inappropriate Set-Up Instructions, which may result in delay in treatment and an unreasonable risk of harm to the patient
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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, 459642, 462192, 462194, 464075, 464076, 465037, 466247, 469921, 470627, 471651,471703, 472562, 472785 and 473725. UDI Code: 00650862100211
- 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…
- Recalling firm
- Atrium Medical Corporation
- Quantity
- 87,972 drains (14,662 cases; 6 units/case)
- Distribution
- US Nationwide Distribution Foreign: Bahrain Belgium Brunei Darussalam Canada Colombia Ecuador Finland Italy Kuwait Libya Mauritius Mexico Netherlands Poland Portugal Russian Federation Saudi Arabia Spain United Arab Emirates United Kingdom of Great Britain and Northern Ireland
- Recall date
- December 1, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)