Maquet Getinge Custom Tubing Sets Recalled Due to Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific Custom Tubing Sets for Extracorporeal Circulation because the stopcock design 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 is classified as FDA Class II and involves a risk of harm (infection due to compromised sterility) without reported illnesses or injuries, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Maquet Cardiovascular, LLC is recalling specific Custom Tubing Sets for Extracorporeal Circulation (ECC). The affected product is the Maquet Getinge BO-T 2303 3/8" x 3/8" Adult Pack, Material 709000004R01, with Batch Number 3000058327. The recall is classified as Class II by the U.S. Food and Drug Administration.
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 during sterilization. This issue means the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured, posing a potential risk of infection if the product is used.
The affected products were distributed nationwide. Healthcare facilities and users should stop using the affected tubing sets and contact Maquet Cardiovascular for further instructions or replacement.
The recalled product
- Product
- Maquet Getinge- BO-T 2303 3/8" x 3/8" Adult Pack Material: 709000004R01
- Manufacturer
- Maquet Cardiovascular, LLC
- Category
- Medical Device — Cardiovascular
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: 3000058327
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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