Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z
Summary
The FDA issued a Class II for Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z by Maquet Cardiovascular, LLC. Reason: Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the p.
Details
Source
Device Recall
External ID
Z-0485-2025
Action Date
2024-11-27
Status
Ongoing
Category
device
Product Description
Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z
Lot/Code Info: Model Number C-OM-9000Z. UDI-DI Number: 00607567900004. Batch Numbers: 3000270477, 3000274130, 3000279333, 3000325028, 3000349295, 3000356305, 3000368568, 3000288446, 3000314841, 3000318197, 3000340989, 3000315179, 3000284660, 3000279342, 3000325025, 3000340964, 3000274640, 3000280059, 3000280563, 3000325362, 3000284695, 3000314838, 3000349055, 3000356063, 3000298982, 3000317739, 3000376711, 3000279839, 3000399170, 3000362853, 3000337154, 3000321412, 3000299814, 3000288445, 3000269996.
Quantity Affected: 10,778 units
Reason for Recall
Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the product's 2-year shelf life.
Distribution
Nationwide distribution. International distribution to Albania, Algeria, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brunei Canada, Croatia, Czech Republic, Denmark, Finland, France and Belarus, Germany, Greece, Hong Kong, India, Indonesia, Italy, Japan, Lebanon, Luxembourg, Malaysia, Netherlands, Oman, Pakistan, Poland, Portugal, Slovenia, South Africa, Spain, Switzerland, the Republic of Korea (South Korea), Turkey, United Arab Emirates, United Kingdom.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-10-16
Company
Wayne, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 280 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 II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
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-0485-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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