HLS Set Advanced with BIOLINE Coating Custom tubing recall: Endotoxin
HLS Set Advanced with BIOLINE Coating Custom tubing packs for the oxygenator
Why was HLS Set Advanced with BIOLINE Coating Custom tubing recalled?
Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
HLS Set Advanced: Small Adult 5.0 with BIOLINE Coating BEQ-HLS 5050, 70105.2797, Adult 7.0 with BIOLINE Coating BEQ-HLS 7050, 70105.2794 and Adult 7.0 with SOFTLINE Coating BO-HLS 7050, 70105.2786
- Product
- HLS Set Advanced with BIOLINE Coating Custom tubing packs for the oxygenator
- Recalling firm
- Maquet Cardiovascular Us Sales, Llc
- Quantity
- 72,000 units in total
- Distribution
- US Nationwide Distribution.
- Recall date
- April 20, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)