Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection
Summary
The FDA issued a Class I for Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection by Maquet Cardiovascular, LLC. 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 pati.
Details
Source
Device Recall
External ID
Z-0709-2024
Action Date
2024-01-24
Status
Ongoing
Category
device
Product Description
Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection
Lot/Code Info: UDI-DI 00650862115130 Lots 499822 490138 499344 498578 499805 498974 498063 497139 495208 496692 487810 489877 489878 496208 496207 496774 495194 495193 494224 493679 492644 492079 490762 490744 487809 489161 485228 483533 487808 485231 486071 485230 483108 485229 483534 475228 475487 483107 483180 477950 474982 474076 474511 472581 473747 474950 474077 474967 469918 469920 471069 471805 471806 469403 470148 468857 469402 469919 467195 468858 468395 468856 467476 467475 466637 466951 467193 467194 466455 467352 466267 466080
Quantity Affected: (34,356 cases/206,136 devices US); (3,902 cases/23,412 devices OUS)
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.
Distribution
Worldwide distribution: US (nationwide) and OUS (Foreign) to countries of: Australia, Brazil, Canada, Luxembourg, Netherlands, Norway, Spain and UK
Type: Voluntary: Firm initiated
Recall Initiated: 2023-12-13
Company
Wayne, NJ
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 203 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Maquet Cardiovascular, LLC has 41 FDA actions in our database, including 37 recalls and 4 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Maquet Cardiovascular, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Maquet Cardiovascular, LLC have FDA actions?
Maquet Cardiovascular, LLC has 41 FDA actions in our database, including 37 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0709-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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