Maquet Getinge BO-TOP 48400 OR PACK Material recall: Sterility Concern
Maquet Getinge BO-TOP 48400 OR PACK Material: 701064327R01
Why was Maquet Getinge BO-TOP 48400 OR PACK 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: 3000045085 3000047033 3000051653 3000056258 3000062266
- Product
- Maquet Getinge BO-TOP 48400 OR PACK Material: 701064327R01
- Recalling firm
- Maquet Cardiovascular, LLC
- Quantity
- N/A
- Distribution
- Nationwide
- Recall date
- June 5, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)