Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Product REF 4000-100N Recalled by Maquet Cardiovascular, LLC Due to Express chest drains are pre-packaged with sterile water...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Maquet Cardiovascular, LLC directly.
Affected Products
Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection
Quantity: (34,356 cases/206,136 devices US); (3,902 cases/23,412 devices OUS)
Why Was This Recalled?
Express chest drains are pre-packaged with sterile water syringes which have bene recalled. If the device is not kept in an upright position, the patient may be exposed to infectious material. Subsequent hazards include but are not limited to infection, abscess, sepsis, and death.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Maquet Cardiovascular, LLC
Maquet Cardiovascular, LLC has 251 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report