Maquet Getinge-T 8028 PRESSURE PIGTAIL 4" Material recall: Sterility Concern
Maquet Getinge-T 8028 PRESSURE PIGTAIL 4" Material: 701055993
Why was Maquet Getinge-T 8028 PRESSURE PIGTAIL 4" 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: 3000054751 3000055509 3000061510 3000066891 3000075388 3000080435 3000080699 3000081533
- Product
- Maquet Getinge-T 8028 PRESSURE PIGTAIL 4" Material: 701055993
- Recalling firm
- Maquet Cardiovascular, LLC
- Quantity
- N/A
- Distribution
- Nationwide
- Recall date
- June 5, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)