Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit
Summary
The FDA issued a Class I for Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit 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-0710-2024
Action Date
2024-01-24
Status
Ongoing
Category
device
Product Description
Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit
Lot/Code Info: UDI-DI 00650862115147 Lots 499345 498062 496693 495731 494226 492645 492078 490763 487811 490139 489162 487849 483249 470644 468860 467477 466952
Quantity Affected: (7,501 cases/45,006 devices US); no 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-0710-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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