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HLS Set Advanced, Model: BEQ-HLS 7050 USA recallZ-0633-2021 · Maquet Cardiovascular Us Sales, Llc · initiated Nov 20, 2020

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Maquet Cardiovascular Us Sales, Llc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product's sterility barrier.

FDA root cause category: Package design/selection

What the company is doing

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 [email protected] 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

Recall details

Recall number
Z-0633-2021
Status
Terminated
Initiated by the company
Nov 20, 2020
Recalling firm
Maquet Cardiovascular Us Sales, Llc
Product code
DTZ
FDA submissions
K112360
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.

Product description

HLS Set Advanced, Model: BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Product Code/Part Number: 70105.2794 - Product Usage: These devices are used with the CARDIOHELP system in order to provide extracorporeal circulation for cardiac support and/or pulmonary support.

Code information (models, lots, serial numbers)

Model Number: BEQ-HLS 7050 Part Number: 70105.2794 UDI Code: 04037691773513 Lot Codes: 70130364, 70132269, 70133476, 70133592, 70133623, 70133624, 70133625, 70134790, 70135038

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

3 devices cleared under K112360 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 86796).

Sources and updates

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