Maquet Medical Systems USA QUADROX-iR, used during cardiopulmonary bypass Model Item No. Description BEQ-HMO 51100-USA 701067936 Small Adult with filter, with BIOLINE Coating BEQ-HMO 71100-USA 701067880 Adult with filter, with BIOLINE Coating HMO 50100-USA 701067934 Small Adult without filter, with SOFTLINE Coating HMO 51100-USA 701067938 Small Adult with filter, with SOFTLINE Coating HMO 70100-USA 701067874 Ad Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
QUADROX-iR, used during cardiopulmonary bypass Model Item No. Description BEQ-HMO 51100-USA 701067936 Small Adult with filter, with BIOLINE Coating BEQ-HMO 71100-USA 701067880 Adult with filter, with BIOLINE Coating HMO 50100-USA 701067934 Small Adult without filter, with SOFTLINE Coating HMO 51100-USA 701067938 Small Adult with filter, with SOFTLINE Coating HMO 70100-USA 701067874 Ad
Brand
Maquet Medical Systems USA
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Model Item No. UDI-DI BEQ-HMO 51100-USA 701067936 n/a BEQ-HMO 71100-USA 701067880 4058863164052 HMO 50100-USA 701067934 n/a HMO 51100-USA 701067938 n/a HMO 70100-USA 701067874 n/a HMO 71100-USA 701067886 n/a All lots
Maquet Medical Systems USA is recalling QUADROX-iR, used during cardiopulmonary bypass Model Item No. due to 1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhib. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026