Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific batches of BO-TOP 48400 OR PACK tubing sets because a design flaw may prevent proper sterilization of the stopcock ports.
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 risk-of-harm product (medical device) where the sterility assurance level cannot be verified, creating a potential risk of infection, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Maquet Cardiovascular, LLC is recalling the Maquet Getinge BO-TOP 48400 OR PACK (Material: 701064327R01). These are custom tubing sets used for extracorporeal circulation (ECC). The recall affects batches 3000045085, 3000047033, 3000051653, 3000056258, and 3000062266, 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 during sterilization. As a result, the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured, meaning the devices may not be fully sterile.
Healthcare facilities and users should stop using the affected tubing sets immediately. Users should contact Maquet Cardiovascular for further instructions on how to return or dispose of the recalled products.
The recalled product
- Product
- Maquet Getinge BO-TOP 48400 OR PACK Material: 701064327R01
- Manufacturer
- Maquet Cardiovascular, LLC
- Category
- Medical Device — Surgical Tubing
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: 3000045085 3000047033 3000051653 3000056258 3000062266
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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