Maquet Cardiovascular Recalls HLS/HIT Set Advanced Due to Blood Leakage Risk
Maquet Cardiovascular is recalling HLS/HIT Set Advanced consoles because a potential issue could cause blood to leak from the gas outlet port.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a potential for blood leakage, which poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity rating.
Plain-English summary
Maquet Cardiovascular US Sales, LLC is recalling the HLS/HIT Set Advanced with Bioline and/or Softline Coating Console. The recall involves 10,199 units distributed worldwide, including the United States and numerous international markets.
The recall was initiated because a potential issue was detected that could result in blood leakage from the gas outlet port. This issue affects all lots of the Quadrox-iD Adult Diffusion Membrane Oxygenator with Bioline and Softline Coatings, Custom Tubing Packs, and Diffusion Membrane HLS Set Advanced and HIT Set Advanced Models.
The affected products are intended for use in hospital environments and for intra- and inter-hospital transport. The recall covers specific part numbers: BEQ-HLS 5050, 70105,2797; BEQ-HLS 7050, 70105.2794; and BO-HLS 7050, 70105.2786. Healthcare facilities should stop using these devices and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- HLS/HIT Set Advanced with Bioline and/or Softline Coating Console Product Usage: HLS/HIT Set Advanced: The CARDIO HELP System in configuration with the HLS/HIT Set Advanced is intended to be used within the hospital environment and outside the hospital environment (for peri
- Manufacturer
- Maquet Cardiovascular Us Sales, Llc
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Part numbers BEQ-HLS 5050
- 70105
- 2797
- BEQ-HLS 7050
- 70105.2794
- and BO-HLS 7050
- 70105.2786
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Maquet Cardiovascular Us Sales, Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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