Recall Z-1638-2023
Maquet Medical Systems USA · initiated May 18, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 70000-USA 701067820 HMO 71000-USA 701067823
Codes / lots: Model Item no. UDI-DI HMO 70000-USA 701067820 4058863019147 HMO 71000-USA 701067823 4058863017341 All lots
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: Pending
Action taken
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.
Details
- Recall number
- Z-1638-2023
- Initiated
- May 18, 2023
- Posted by FDA
- May 26, 2023
- Product code
- DTZ – Oxygenator, Cardiopulmonary Bypass
- Quantity
- 0 (US)
- Distribution
- Domestic distribution nationwide.
- Recalling firm
- Maquet Medical Systems USA, Wayne, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1634-2023 Class II | HMOD 70000-USA/QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Item no.…1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's… | 05/18/2023Open, Classified |
| Z-1635-2023 Class II | BEQ-HMOD70000-USA/QUADROX-iD, Oxygenator used during cardiopulmonary bypass Item no.…1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory s… | 05/18/2023Open, Classified |
| Z-1636-2023 Class II | BEQ-HMO 50000-USA/ QUADROX-i Small, Oxygenator used during cardiopulmonary bypass Item…1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's… | 05/18/2023Open, Classified |
| Z-1637-2023 Class II | QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. HMO…1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's… | 05/18/2023Open, Classified |
| Z-1639-2023 Class II | BEQ-HMO 71000-USA /QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Item…1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's… | 05/18/2023Open, Classified |
| Z-1640-2023 Class II | QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item no. HMO…1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's… | 05/18/2023Open, Classified |
| Z-1641-2023 Class II | QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO…1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's… | 05/18/2023Open, Classified |
| Z-1642-2023 Class II | Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No.…1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's… | 05/18/2023Open, Classified |
| Z-1643-2023 Class II | QUADROX-iR, used during cardiopulmonary bypass Model Item No. Description BEQ-HMO…1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's… | 05/18/2023Open, Classified |