Class I — Serious Health Hazard

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 4050-100N Recalled by Maquet Cardiovascular, LLC Due to Express chest drains are pre-packaged with sterile water...

Date: December 13, 2023
Company: Maquet Cardiovascular, LLC
Status: Ongoing
Source: FDA (Device)

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 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit

Quantity: (7,501 cases/45,006 devices US); no 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.

Affected (51 states)Not affected

About Maquet Cardiovascular, LLC

Maquet Cardiovascular, LLC has 251 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report