Maquet Getinge-BEQ-TOP 25003 3/8X3/8 TO 7LPM Material recall: Sterility Concern
Maquet Getinge-BEQ-TOP 25003 3/8X3/8 TO 7LPM Material: 701063255
Why was Maquet Getinge-BEQ-TOP 25003 3/8X3/8 TO 7LPM Material 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: 3000041007 3000044052 3000045730 3000047318 3000054334 3000054615 3000063091
- Product
- Maquet Getinge-BEQ-TOP 25003 3/8X3/8 TO 7LPM Material: 701063255
- Recalling firm
- Maquet Cardiovascular, LLC
- Quantity
- N/A
- Distribution
- Nationwide
- Recall date
- June 5, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)