Maquet Getinge-BO-TOP 14605 OPEN HEART WITHOU Material recall: Sterility Concern
Maquet Getinge-BO-TOP 14605 OPEN HEART WITHOU Material: 701067372
Why was Maquet Getinge-BO-TOP 14605 OPEN HEART WITHOU 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: 3000047035 3000051157 3000056254 3000059729 3000062036 3000063395
- Product
- Maquet Getinge-BO-TOP 14605 OPEN HEART WITHOU Material: 701067372
- Recalling firm
- Maquet Cardiovascular, LLC
- Quantity
- N/A
- Distribution
- Nationwide
- Recall date
- June 5, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)