Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit
Reported: January 24, 2024 Initiated: December 13, 2023 #Z-0710-2024
Product Description
Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit
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.
Details
- Recalling Firm
- Maquet Cardiovascular, LLC
- Units Affected
- (7,501 cases/45,006 devices US); no OUS
- Distribution
- Worldwide distribution: US (nationwide) and OUS (Foreign) to countries of: Australia, Brazil, Canada, Luxembourg, Netherlands, Norway, Spain and UK
- Location
- Wayne, NJ
Frequently Asked Questions
What product was recalled? ▼
Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit. Recalled by Maquet Cardiovascular, LLC. Units affected: (7,501 cases/45,006 devices US); no OUS.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 24, 2024. Severity: Critical. Recall number: Z-0710-2024.
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