HLS Set Advanced recall: Sterility Concern
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…
Why was HLS Set Advanced recalled?
The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product's sterility barrier.
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?
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
- Product
- 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…
- Recalling firm
- Maquet Cardiovascular Us Sales, Llc
- Quantity
- 58,438 devices worldwide
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Argentina, Australia, Austria, Belgium, Brazil, Brunei Darussal, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Kosovo, Kuwait, Latvia, Lebanon, Luxembourg, Macedonia, Malaysia, Mexico, Moldavia, Montenegro, Morocco, Myanmar, Netherlands, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand,Turkey, United Arab Emirates, United Kingdom, Vietnam.
- Recall date
- December 23, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)