BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078. Used with the CARDIOHELP heart-lung machi
Summary
The FDA issued a Class II for BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078. U by Maquet Medical Systems USA. Reason: The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconformities at the bag seal. This issue may .
Details
Source
Device Recall
External ID
Z-1077-2024
Action Date
2024-02-21
Status
Ongoing
Category
device
Product Description
BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078. Used with the CARDIOHELP heart-lung machine.
Lot/Code Info: UDI-DI 04058863080383 Lots 3000280906, 3000280907, 3000280908, 3000280909, 3000282253, 3000282254, 3000282255, 3000291127, 3000300688, 3000314506, 3000316206, 3000316600, 3000317531, 3000317532, 3000318850, 3000318851, 3000318852, 3000318853, 3000319748, 3000319749, 3000319750, 3000319751, 3000319778, 3000319781, 3000323082, 3000323084, 3000323085, 3000324495, 3000324496, 3000324497, 3000324499, 3000325557, 3000325558, 3000325559, 3000327120, 3000327121, 3000328404, 3000328405, 3000334413, 3000334414, 3000336487 ***Added 3/21/24*** 3000330091, 3000330092, 3000330094, 3000330095, 3000330096, 3000333095, 3000333096, 3000333097, 3000334409, 3000334410, 3000336488, 3000337834, 3000342904, 3000342905, 3000342906, 3000342907, 3000342908, 3000344446, 3000344447, 3000344471, 3000344472, 3000344474, 3000346048, 3000346049, 3000346050, 3000346051, 3000346052, 3000348543, 3000348546, 3000348552, 3000348553, 3000349793, 3000349795, 3000349796, 3000349797, 3000352614, 3000352615, 3000352616, 3000352617, 3000353439, 3000353440
Quantity Affected: 16520 worldwide; 6657 US
Reason for Recall
The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconformities at the bag seal. This issue may result in inflammation, sepsis, or infection.
Distribution
Worldwide - US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-01-16
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 164 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Maquet Medical Systems USA has 36 FDA actions in our database, including 36 recalls.
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 Medical Systems USA) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Maquet Medical Systems USA have FDA actions?
Maquet Medical Systems USA has 36 FDA actions in our database, including 36 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1077-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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