Recall Z-0709-2024— Maquet Cardiovascular, LLC
Class I · Ongoing
Class I FDA medical device recall by Maquet Cardiovascular, LLC, initiated 2023-12-13. It names one FDA 510(k) clearance: K043140. Product: Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection. Reason: 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..
- Recalling firm
- Maquet Cardiovascular, LLC
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2023-12-13
- Firm location
- Wayne, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.