Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific Custom Tubing Sets for Extracorporeal Circulation because a design feature may prevent proper sterilization, potentially compromising sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 harm (infection) without reported injuries, which aligns with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Maquet Cardiovascular, LLC is recalling specific batches of Custom Tubing Sets for Extracorporeal Circulation (ECC). The affected products are the BO-TOP 36504 Adult ECC Pack, identified by material numbers 701065765R01 and 701065765R02. The recall covers specific batch numbers: 3000058184, 3000067382, 3000069380, 3000071967, 3000074322, and 3000077734. These products 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 the sterilization process. As a result, the Sterility Assurance Level (SAL) for the stopcock ports cannot be assured, which poses a risk of non-sterile equipment being used in medical procedures.
Healthcare facilities and consumers who have these specific products should stop using them and contact Maquet Cardiovascular, LLC for instructions on return or replacement. The U.S. Food and Drug Administration has classified this as a Class II recall.
The recalled product
- Product
- Maquet Getinge- (1)Material: 701065765R01 BO-TOP 36504 Adult ECC Pack (2)Material: 701065765R02 BO-TOP 36504 Adult ECC Pack
- 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 (5)
- Batch Numbers: (1)3000058184
- 3000067382
- 3000069380
- 3000071967
- 3000074322 (2)3000077734
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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