Maquet Getinge-BEQ-T 53400 Adaption Pack Recall for Sterility Assurance Issues
Maquet Cardiovascular is recalling specific batches of Custom Tubing Sets for Extracorporeal Circulation because the stopcock design may prevent proper sterilization.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where the Sterility Assurance Level cannot be assured, creating a risk of infection or harm, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Maquet Cardiovascular, LLC is recalling specific batches of Maquet Getinge-BEQ-T 53400 Adaption Packs (Material: 709000213). These products are Custom Tubing Sets used for Extracorporeal Circulation (ECC). The recall affects batch numbers 3000047192, 3000049558, and 3000067521, which were distributed nationwide.
The recall was initiated because the closed stopcock and non-vented cap configuration may prevent the flow of humidity and ethylene oxide gas into the fluid path between the closed port and the cap. This design issue means the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured during the sterilization process.
Healthcare facilities and users of these products should stop using the affected batches immediately. The source text does not provide specific instructions for disposal or replacement, but users should contact the manufacturer or their supplier for guidance on handling the recalled items.
The recalled product
- Product
- Maquet Getinge-BEQ-T 53400 Adaption Pack Material: 709000213
- Manufacturer
- Maquet Cardiovascular, LLC
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Batch Numbers: 3000047192 3000049558 3000067521
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 183 recalled by Maquet Cardiovascular, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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