FDA Recalls Express Chest Drain Blood Recovery Units Over Infection Risk
Maquet Cardiovascular is recalling Express chest drain units with defective sterile water syringes. If not kept upright, patients risk exposure to infectious material that may cause infection, abscess, sepsis, or 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: This is an FDA Class I recall for a medical device with potential for serious patient harm. The defective syringes can expose patients to infectious material, risking infection, abscess, sepsis, and death. Although no deaths have been documented, the Class I classification and severity of potential complications justify a Severe rating.
Plain-English summary
Maquet Cardiovascular, LLC is recalling Express chest drain units (Model REF 4050-100N, Blood Recovery Unit) distributed in the United States and internationally to Australia, Brazil, Canada, Luxembourg, Netherlands, Norway, Spain, and the United Kingdom. The units contain pre-packaged sterile water syringes that have been recalled.
When these chest drain units are not kept in an upright position, patients may be exposed to infectious material. This exposure creates risk of infection, abscess, sepsis, and potentially death.
Healthcare providers using affected lots should verify device lot numbers, ensure proper upright positioning during all use, and contact the manufacturer for return or replacement instructions. The affected lot numbers are: 499345, 498062, 496693, 495731, 494226, 492645, 492078, 490763, 487811, 490139, 489162, 487849, 483249, 470644, 468860, 467477, and 466952. This is an FDA Class I recall due to the potential for serious patient harm.
The recalled product
- Product
- Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit
- Manufacturer
- Maquet Cardiovascular, LLC
- Category
- Medical Device
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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