HLS Set Advanced Model Name: BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code/Part Number: 70105.2797 - Product Usage: These devices are used with the CARDIOHELP system in order to provide extracorporeal circulation for cardiac support and/or pulmonary support.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model Number: BEQ-HLS 5050 Part Number: 70105.2797 UDI Code: 04037691773513 Lot Codes: 70127790, 70127791, 70127792, 70127793, 70127921, 70127922, 70127923, 70127924, 70128195, 70128196, 70128197, 70128328, 70128329, 70128330, 70128331, 70129242, 70129243, 70129244, 70129245, 70129380, 70129381, 70129382, 70129383, 70129469, 70129470, 70129471, 70129472, 70129556, 70129557, 70129558, 70129559, 70129634, 70129635, 70129637, 70129638, 70129849, 70129850, 70130071, 70130072, 70130207, 70130208, 70130209, 70130883, 70130884, 70130885, 70130886, 70131090, 70131091, 70131092, 70131093, 70131159, 70131160, 70131161, 70131162, 70131405, 70131406, 70131407, 70131408, 70131474, 70131475, 70131587, 70131588, 70131589, 70131590, 70131976, 70131977, 70131978, 70131979, 70132435, 70132652, 70132653, 70132845, 70132861, 70132862, 70132903, 70132904, 70133056, 70133057, 70133102, 70133103, 70133472, 70133473, 70133474, 70133475, 70133528, 70133634, 70133636, 70133637, 70133751, 70133752, 70133753, 70133754, 70133755, 70133756, 70133757, 70133758, 70133759, 70133760, 70133761, 70133762, 70133763, 70133764, 70134019, 70134020, 70134021, 70134022, 70134023, 70134025, 70134028, 70134750, 70134751, 70134752, 70134753, 70134754, 70134755, 70135250, 70135251, 70135252, 70135253, 70135254, 70135255, 70135256, 70135257, 70135258, 70136150, 70136151, 70136152
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Maquet Cardiovascular Us Sales, Llc
- Reason for Recall:
- The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product's sterility barrier.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
HLS Set Advanced Model Name: BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code/Part Number: 70105.2797 - Product Usage: These devices are used with the CARDIOHELP system in order to provide extracorporeal circulation for cardiac support and/or pulmonary support.
Product Codes/Lot Numbers:
Model Number: BEQ-HLS 5050 Part Number: 70105.2797 UDI Code: 04037691773513 Lot Codes: 70127790, 70127791, 70127792, 70127793, 70127921, 70127922, 70127923, 70127924, 70128195, 70128196, 70128197, 70128328, 70128329, 70128330, 70128331, 70129242, 70129243, 70129244, 70129245, 70129380, 70129381, 70129382, 70129383, 70129469, 70129470, 70129471, 70129472, 70129556, 70129557, 70129558, 70129559, 70129634, 70129635, 70129637, 70129638, 70129849, 70129850, 70130071, 70130072, 70130207, 70130208, 70130209, 70130883, 70130884, 70130885, 70130886, 70131090, 70131091, 70131092, 70131093, 70131159, 70131160, 70131161, 70131162, 70131405, 70131406, 70131407, 70131408, 70131474, 70131475, 70131587, 70131588, 70131589, 70131590, 70131976, 70131977, 70131978, 70131979, 70132435, 70132652, 70132653, 70132845, 70132861, 70132862, 70132903, 70132904, 70133056, 70133057, 70133102, 70133103, 70133472, 70133473, 70133474, 70133475, 70133528, 70133634, 70133636, 70133637, 70133751, 70133752, 70133753, 70133754, 70133755, 70133756, 70133757, 70133758, 70133759, 70133760, 70133761, 70133762, 70133763, 70133764, 70134019, 70134020, 70134021, 70134022, 70134023, 70134025, 70134028, 70134750, 70134751, 70134752, 70134753, 70134754, 70134755, 70135250, 70135251, 70135252, 70135253, 70135254, 70135255, 70135256, 70135257, 70135258, 70136150, 70136151, 70136152
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0632-2021
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