Recall Z-0632-2021
Maquet Cardiovascular Us Sales, Llc · initiated November 20, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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 the CARDIOHELP system in order to provide extracorporeal circulation for cardiac support and/or pulmonary support.
Codes / lots: 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…
Reason for recall
The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product's sterility barrier.
FDA-determined cause: Package design/selection
Action taken
Actions to be taken: Please examine your inventory immediately to determine if you have any of the affected HLS Set Advanced with the product codes and lot numbers listed on page 1 of this notice and acknowledge that you have received this notification by following the instructions below. If an affected device is already in use, please continue using according to normal practices. Should you have any un-used and un-expired affected product you are eligible to return the affected product for credit. Please contact Getinge Customer Service at (888) 9GETUSA / (800) 943-8872 (press option 2) between the hours of 8:00 a.m. and 6:00 p.m. Eastern Standard Time to request a return authorization (RMA) and shipping instructions to return any affected product. Pack the product to be returned with the appropriate return documents and, using the shipping instructions provided, arrange for pickup with the designated delivery service provider. Please also enter the affected lot numbers, quantity and RMA number provided by Customer Service in the spaces provided on the Medical Device Recall Expansion - Removal Response Form on Page 4 of this letter, if you are returning products to Maquet/Getinge. Please complete and sign the attached MEDICAL DEVICE RECALL Removal RESPONSE FORM (page 4) to acknowledge that you have received this notification. Return the completed form to Maquet/Getinge by e-mailing a scanned copy to acthlsset2020.us@getinge.com or by faxing the form to (800) 866-5751. This voluntary recall only affects the products listed on page 1; no other products are affected by this voluntary recall. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online, by regular mail or by fax using the following: " Online: www.accessdata.fda.gov/scripts/medwatch/ " Regular Mail: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088
Details
- Recall number
- Z-0632-2021
- Initiated
- November 20, 2020
- Terminated
- November 7, 2024
- Product code
- DTZ – Oxygenator, Cardiopulmonary Bypass
- 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…
- Recalling firm
- Maquet Cardiovascular Us Sales, Llc, Wayne, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0633-2021 Class II | HLS Set Advanced, Model: BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Product Code/Part…The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product's… | 11/20/2020Terminated |