Maquet Getinge-BEQ-TOP 24202 ADULT ECC Material: 701054295R01
Reported: June 5, 2019 Initiated: April 18, 2019 #Z-1647-2019
Product Description
Maquet Getinge-BEQ-TOP 24202 ADULT ECC Material: 701054295R01
Reason for Recall
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
Details
- Recalling Firm
- Maquet Cardiovascular, LLC
- Units Affected
- N/A
- Distribution
- Nationwide
- Location
- Wayne, NJ
Frequently Asked Questions
What product was recalled? ▼
Maquet Getinge-BEQ-TOP 24202 ADULT ECC Material: 701054295R01. Recalled by Maquet Cardiovascular, LLC. Units affected: N/A.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 5, 2019. Severity: Moderate. Recall number: Z-1647-2019.
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