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U.S. Department of Health and Human Services

Class 2 Device Recall HLS Set Advanced 5.0

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 Class 2 Device Recall HLS Set Advanced 5.0see related information
Date Initiated by FirmJanuary 16, 2024
Date PostedFebruary 13, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1076-2024
Recall Event ID 93849
510(K)NumberK112360 
Product Classification Oxygenator, cardiopulmonary bypass - Product Code DTZ
ProductModel No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 70106.9077. Used with the CARDIOHELP heart-lung machine.
Code Information UDI-DI 04058863076355 Lots 3000301222, 3000319782, 3000327602 ***Added 3/21/24*** 3000333098, 3000352360, 3000357174
Recalling Firm/
Manufacturer		 Maquet Medical Systems USA
45 Barbour Pond Dr
Wayne NJ 07470-2094
For Additional Information ContactMs. Allison Jean Kaplan
973-709-7000
Manufacturer Reason
for Recall		The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconformities at the bag seal. This issue may result in inflammation, sepsis, or infection.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn January 16, 2024, the recalling firm began notifying affected customers via URGENT MEDICAL DEVICE CORRECTION letters. Customers were instructed to dispose of any Emergency Priming Line from a previously opened, affected HLS set. Customers should only use the Emergency Priming Line from a newly opened HLS Set. Device users should always have an HLS Set ready as a backup during therapy. The remaining components of the backup HLS Set must be disposed of after extraction of the Emergency Priming Line. Please reach out to Getinge Customer Support for the issuance of a replacement HLS Set at no cost. Customers may also return unopened/unexpired affected HLS Sets by contacting Customer Support. If an affected Emergency Priming Line is already in use, the firm advises it should remain in use due to increased potential risk of stopping this emergency procedure. Users should monitor the patient closely for signs of infection. Contact Getinge Customer Support: (888) 943-8872 (press option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone). ***Updated 3/21/24*** Additional lots identified. Firm notified affected customers on March 21, 2024.
Quantity in Commerce16520 worldwide; 6657 US
DistributionWorldwide - US Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = DTZ
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