Maquet Getinge-BEQ-TOP 38302 INFANT CPS QPID Material recall: Sterility Concern
Maquet Getinge-BEQ-TOP 38302 INFANT CPS QPID Material: 701055866
Why was Maquet Getinge-BEQ-TOP 38302 INFANT CPS QPID 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: 3000045221 3000049201 3000054750 3000062046 3000065497 3000067793 3000069723 3000072247 3000075339 3000080720 3000084636
- Product
- Maquet Getinge-BEQ-TOP 38302 INFANT CPS QPID Material: 701055866
- Recalling firm
- Maquet Cardiovascular, LLC
- Quantity
- N/A
- Distribution
- Nationwide
- Recall date
- June 5, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)