Reported Jan 24, 2024 · Ongoing
Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection
Maquet Cardiovascular, LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Maquet Cardiovascular, LLC · 45 Barbour Pond Dr · Wayne, NJ · 07470-2094
Is this the product you have?
- Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection
- Lot codes and dates
- UDI-DI 00650862115130 Lots
72 of 72 codes
499822490138499344498578499805498974498063497139495208496692487810489877489878496208496207496774495194495193494224493679492644492079490762490744487809489161485228483533487808485231486071485230483108485229483534475228475487483107483180477950474982474076474511472581473747474950474077474967469918469920471069471805471806469403470148468857469402469919467195468858
- UDI-DI 00650862115130 Lots
- Amount recalled
- (34,356 cases/206,136 devices US); (3,902 cases/23,412 devices OUS)
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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