Maquet Getinge-BEQ-T 9410 Lurie Chldns Small 1/4 recall: Sterility Concern
Maquet Getinge-BEQ-T 9410 Lurie Chldns Small 1/4 Material: 709000430
Why was Maquet Getinge-BEQ-T 9410 Lurie Chldns Small 1/4 recalled?
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Batch Numbers: 3000060035 3000065494 3000067883 3000071809 3000074480 3000075340 3000077550
- Product
- Maquet Getinge-BEQ-T 9410 Lurie Chldns Small 1/4 Material: 709000430
- Recalling firm
- Maquet Cardiovascular, LLC
- Quantity
- N/A
- Distribution
- Nationwide
- Recall date
- June 5, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)