Recall Z-0436-2019
Maquet Cardiovascular Us Sales, Llc · initiated October 25, 2018
Class I – dangerous or defective products that could cause serious health problems or death
Product
QUADROX-i Neonatal without integrated arterial filter and VHK 11000 (VKMO 10000-USA#QUADROX-i Neo.+Reservoir), Part Number 701055120 The membrane oxygenator QUADROXi Neonatal is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.
Codes / lots: UDI: 04037691780139; Lots: 92212343, 92214685, 92225187
Reason for recall
There is a potential for blood leakage at the blood inlet connector when using the reducing screw adapter 1/4 x 3/16 that may result in clinically relevant loss of prime before patient connection or blood loss during patient connection.
FDA-determined cause: Nonconforming Material/Component
Action taken
The firm, GETTINGE, sent an "URGENT MEDICAL DEVICE RECALL" notification letters dated 10/25/18 to customers. The letters described the product, problem, and actions to be taken. The customers were instructed to do the following: -Please immediately examine your inventory to determine if you have any of the QUAD ROX-i Neonatal Oxygenator with the product codes/lot numbers listed in this notice. -If you wish to use the product, please remove and do not use the enclosed reducing screw adapter 1/4" x 3/16" (Ref. No. 70104.8593). -If you do not wish to use the product as packaged, please contact Maquet/Ge tinge Customer Support at +l (888) 627-8383 (press option 2, then option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone) to obtain instructions on returning the affected product for a full credit. Please note that this product is no longer being offered in the United States, and therefore product replacement is not available. -Please complete and sign the attached MEDICAL DEVICE RECALL- RESPONSE FORM (page 4) to acknowledge that you have received this notification. Return the completed form to Maquet/Ge tinge by e-mailing a scanned copy to neoguadroxi2018@getinge.com or by f axing the form to +l (800) 859-8371. If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action. If you have any questions, please contact your Maquet Cardiopulmonary /Ge tinge representative or call the Maquet Cardiopulmonary /Ge tinge Customer Support at +l (888) 627-8383 (press option 2, then option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).
Details
- Recall number
- Z-0436-2019
- Initiated
- October 25, 2018
- Posted by FDA
- November 28, 2018
- Terminated
- June 5, 2020
- Product code
- DTZ – Oxygenator, Cardiopulmonary Bypass
- Quantity
- 490 total in US
- Distribution
- Worldwide Distribution: US (nationwide) to states of: AZ, CA, FL, IA, LA, NC, and TX and countries of: Canada, Argentina, Brazil, Chile, Colombia, Mexico, Uruguay, United Arab Emirates, Belgium, Switzerland, Germany, Egypt, Spain, France, United Kingdom, Ireland, Italy, Lebanon, Netherlands, Pakistan, Portugal, Reunion, Saudi Arabia, Sweden, South Africa, Poland, Serbia, Russia, Turkey, Ukraine…
- Recalling firm
- Maquet Cardiovascular Us Sales, Llc, Wayne, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0437-2019 Class I | QUADROX-i Neonatal with integrated arterial filter and VHK 11000 (VKMO…There is a potential for blood leakage at the blood inlet connector when using the reducing screw adapter… | 10/25/2018Terminated |