Maquet Getinge-BEQ-T 4903 Mercy Med w/o Oxy recall: Sterility Concern
Maquet Getinge-BEQ-T 4903 Mercy Med w/o Oxy Material:701066664
Why was Maquet Getinge-BEQ-T 4903 Mercy Med w/o Oxy 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: 3000041468 3000053105 3000054552 3000057683 3000059795 3000065086 3000067186 3000069077 3000071375 3000072684 3000074341 3000075431 3000078942 3000080722 3000081524 3000084050
- Product
- Maquet Getinge-BEQ-T 4903 Mercy Med w/o Oxy Material:701066664
- Recalling firm
- Maquet Cardiovascular, LLC
- Quantity
- N/A
- Distribution
- Nationwide
- Recall date
- June 5, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)