Maquet Getinge-T 8029 Pressure Pigtail Recall Due to Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific Pressure Pigtail devices because a design feature may prevent proper sterilization, potentially compromising sterility.
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 sterility cannot be assured, posing a risk of infection (risk-of-harm product) without reported injuries or illnesses in the source text, which aligns with the 'High' severity criteria.
Plain-English summary
Maquet Cardiovascular, LLC is recalling the Maquet Getinge-T 8029 Pressure Pigtail 6" (Material: 701055995). The recall involves specific batch numbers: 3000058045, 3000069467, 3000072507, and 3000080702. These devices were distributed nationwide.
The recall is being conducted because the closed stopcock and non-vented cap configuration may prevent the flow of humidity and ethylene oxide gas into the fluid path during the sterilization process. This design issue means the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured, potentially leaving the device non-sterile.
Healthcare facilities and users of these Custom Tubing Sets for Extracorporeal Circulation should stop using the affected units and contact Maquet Cardiovascular for further instructions on return or replacement.
The recalled product
- Product
- Maquet Getinge-T 8029 PRESSURE PIGTAIL 6" Material: 701055995
- 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: 3000058045 3000069467 3000072507 3000080702
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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