Maquet Getinge- BEQ-TOP 5210 ECC Set - Respiratory recall: Sterility Concern
Maquet Getinge- BEQ-TOP 5210 ECC Set - Respiratory Material: 701055604R01
Why was Maquet Getinge- BEQ-TOP 5210 ECC Set - Respiratory 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: 3000044876 3000047906 3000051750 3000056130 3000061303 3000062457 3000071820
- Product
- Maquet Getinge- BEQ-TOP 5210 ECC Set - Respiratory Material: 701055604R01
- Recalling firm
- Maquet Cardiovascular, LLC
- Quantity
- N/A
- Distribution
- Nationwide
- Recall date
- June 5, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)