Maquet Getinge-BEQ-TOP 5909 1/4 PACK W QPID Material recall: Sterility Concern
Maquet Getinge-BEQ-TOP 5909 1/4 PACK W QPID Material: 701064992
Why was Maquet Getinge-BEQ-TOP 5909 1/4 PACK W 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: 3000043679 3000047252 3000050833 3000053134 3000054956 3000056048 3000060481 3000063710 3000067185 3000071400 3000073429 3000075387 3000075899
- Product
- Maquet Getinge-BEQ-TOP 5909 1/4 PACK W QPID Material: 701064992
- Recalling firm
- Maquet Cardiovascular, LLC
- Quantity
- N/A
- Distribution
- Nationwide
- Recall date
- June 5, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)