Product recall
Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit
Why was 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI 00650862115147 Lots 499345 498062 496693 495731 494226 492645 492078 490763 487811 490139 489162 487849 483249 470644 468860 467477 466952
- Product
- Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit
- Recalling firm
- Maquet Cardiovascular, LLC
- Quantity
- (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
- Recall date
- January 24, 2024
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)