Maquet Getinge-BEQ-TOP 8013 ECC QUADROX iD Pack RF32 recall: Sterility Concern
Maquet Getinge-BEQ-TOP 8013 ECC QUADROX iD Pack RF32 Material: 701047962
Why was Maquet Getinge-BEQ-TOP 8013 ECC QUADROX iD Pack RF32 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: 3000047630 3000050482 3000055980 3000060726 3000066813 3000068491 3000070813 3000074323
- Product
- Maquet Getinge-BEQ-TOP 8013 ECC QUADROX iD Pack RF32 Material: 701047962
- Recalling firm
- Maquet Cardiovascular, LLC
- Quantity
- N/A
- Distribution
- Nationwide
- Recall date
- June 5, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)