Express Chest Drains Recalled for Infection Risk from Recalled Syringes
Maquet Cardiovascular is recalling Express chest drains pre-packaged with recalled sterile water syringes. If not kept upright, patients may be exposed to infectious material, risking infection, abscess, sepsis, and death.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA classified this as Class I, which mandates a minimum Severe (4) severity rating. Although the defect creates risk of serious infection and death, no adverse events have been formally reported.
Plain-English summary
Maquet Cardiovascular, LLC is recalling its Express chest drain products (Product REF 4000-100N) due to a packaging defect. The devices come pre-packaged with sterile water syringes that have been separately recalled.
If the drain is not maintained in an upright position, patients may be exposed to infectious material. This exposure can lead to serious infections, abscesses, sepsis, and in severe cases, death.
The recall affects 34,356 cases containing 206,136 devices distributed in the United States and an additional 3,902 cases containing 23,412 devices distributed internationally (Australia, Brazil, Canada, Luxembourg, Netherlands, Norway, Spain, and the UK).
Healthcare facilities and patients should immediately stop using affected devices and contact Maquet Cardiovascular for replacement.
The recalled product
- Product
- Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection
- Manufacturer
- Maquet Cardiovascular, LLC
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Maquet Cardiovascular, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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