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 Adult without filter, with SOFTLINE Coating HMO 71100-USA 701067886 Adult with filter, with SOFTLINE Coating
- Company
- Maquet Medical Systems, Usa
- Recall Initiated
- May 18, 2023
- Posted
- May 26, 2023
- Recall Number
- Z-1643-2023
- Quantity
- 0 (US)
- Firm Location
- Wayne, NJ
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.
Distribution
Domestic distribution nationwide.
Lot / Code Info
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
Root 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.