Maquet Getinge-BEQ-TOP 1601#QUADROX iD - Pack recall: Sterility Concern
Maquet Getinge-BEQ-TOP 1601#QUADROX iD - Pack Material:701052285
Why was Maquet Getinge-BEQ-TOP 1601#QUADROX iD - Pack 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: 3000048235 3000056129 3000059730 3000065496 3000070700 3000073428
- Product
- Maquet Getinge-BEQ-TOP 1601#QUADROX iD - Pack Material:701052285
- Recalling firm
- Maquet Cardiovascular, LLC
- Quantity
- N/A
- Distribution
- Nationwide
- Recall date
- June 5, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)