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Class 2 Device Recall HLS Set Advanced 7.0 |
 |
| Date Initiated by Firm |
January 16, 2024 |
| Date Posted |
February 13, 2024 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-1077-2024 |
| Recall Event ID |
93849 |
| 510(K)Number |
K112360
|
| Product Classification |
Oxygenator, cardiopulmonary bypass - Product Code DTZ
|
| Product |
BEQ-HLS 7050 USA,
HLS Set Advanced 7.0, Product Code/Part Number 70106.9078. Used with the CARDIOHELP heart-lung machine. |
| Code Information |
UDI-DI 04058863080383
Lots 3000280906, 3000280907, 3000280908,
3000280909, 3000282253, 3000282254,
3000282255, 3000291127, 3000300688,
3000314506, 3000316206, 3000316600,
3000317531, 3000317532, 3000318850,
3000318851, 3000318852, 3000318853,
3000319748, 3000319749, 3000319750,
3000319751, 3000319778, 3000319781,
3000323082, 3000323084, 3000323085,
3000324495, 3000324496, 3000324497,
3000324499, 3000325557, 3000325558,
3000325559, 3000327120, 3000327121,
3000328404, 3000328405, 3000334413,
3000334414, 3000336487
***Added 3/21/24***
3000330091,
3000330092, 3000330094, 3000330095,
3000330096, 3000333095, 3000333096,
3000333097, 3000334409, 3000334410,
3000336488, 3000337834, 3000342904,
3000342905, 3000342906, 3000342907,
3000342908, 3000344446, 3000344447,
3000344471, 3000344472, 3000344474,
3000346048, 3000346049, 3000346050,
3000346051, 3000346052, 3000348543,
3000348546, 3000348552, 3000348553,
3000349793, 3000349795, 3000349796,
3000349797, 3000352614, 3000352615,
3000352616, 3000352617, 3000353439,
3000353440 |
Recalling Firm/
Manufacturer |
Maquet Medical Systems USA
45 Barbour Pond Dr
Wayne NJ 07470-2094
|
| For Additional Information Contact |
Ms. 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 |
| Action |
On 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 Commerce |
16520 worldwide; 6657 US |
| Distribution |
Worldwide - US Nationwide distribution. |
| Total Product Life Cycle |
TPLC Device Report
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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.
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| 510(K) Database |
510(K)s with Product Code = DTZ and Original Applicant = MAQUET CARDIOPULMONARY AG
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