| Class 2 Device Recall QUADROXi Neonatal | |
Date Initiated by Firm | May 18, 2023 |
Date Posted | May 26, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1640-2023 |
Recall Event ID |
92003 |
510(K)Number | K102464 |
Product Classification |
Oxygenator, cardiopulmonary bypass - Product Code DTZ
|
Product | QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass
Model Item no.
HMO 10000-USA 701070412
HMO 11000-USA 701070416 |
Code Information |
Model Item no. UDI-DI
HMO 10000-USA 701070412 4058863154473
HMO 11000-USA 701070416 4058863154558
All lots |
Recalling Firm/ Manufacturer |
Maquet Medical Systems USA 45 Barbour Pond Dr Wayne NJ 07470-2094
|
For Additional Information Contact | Maryanna Krivak 973-709-7483 |
Manufacturer Reason for Recall | 1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's
sterile pouch.
2. Product packaging may exhibit holes, cracks, dents, and crushed areas.
Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia. |
FDA Determined Cause 2 | Pending |
Action | On May 18, 2023, the firm notified customers of the recall via an Urgent Medical Device Removal letter.
Actions to be taken by the customer:
If an affected device is already in use, please use according to normal practices. Monitor the patient for signs and symptoms of inflammation, infection, sepsis, and ischemia. If detected, treat according to clinical protocols.
Please remove any affected product in inventory from areas of use. Unopened and unexpired affected product is eligible for credit upon return.
Product Return: Please contact Getinge Customer Service at 1-888-943-8872 option 2 between the
hours of 6:00 AM and 5:00 PM Pacific Standard Time to request a return authorization (RMA) and
shipping instructions to return any affected product.
Distributors who have shipped affected products to customers should forward the notification to customers' attention for appropriate action.
Maquet Cardiopulmonary GmbH is working with all possible urgency on the redesign and revalidation of a
packaging solution, which is anticipated to be available by Q4 2023. |
Quantity in Commerce | 0 (US) |
Distribution | Domestic distribution nationwide. |
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
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