Reported Jun 3, 2015 · Terminated
HLS/HIT Set Advanced with Bioline and/or Softline Coating Console Product Usage: HLS/HIT Set Advanced: The CARDIO HELP…
Maquet Cardiovascular US Sales, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Maquet Cardiovascular Us Sales, Llc · 45 Barbour Pond Drive · Wayne, NJ · 07470
Is this the product you have?
- HLS/HIT Set Advanced with Bioline and/or
- Softline Coating Console Product UsageHLS/HIT
- Set AdvancedThe 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 periods up to six hours), e.g. for intra- and inter-hospital transport. Due to its system combination of integrated oxygenator and centrifugal pump, the HLS Set Advanced is suitable for both extracorporeal pulmonary support and cardiovascular support, and for simultaneous cardiovascular and pulmonary support
- Lot codes and dates
Part numbers BEQ-HLS 5050701052797BEQ-HLS 705070105.2794and BO-HLS 705070105.2786
- Amount recalled
- 10, 199 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
A potential issue was detected that could result in blood leakage from the gas outlet port in all lots of 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.
This product could cause temporary or reversible health problems — stop using it.
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