Maquet Getinge ECC Tubing Sets Recalled for Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific ECC tubing sets 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 infection or harm to patients, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Maquet Cardiovascular, LLC is recalling Maquet Getinge-BEQ-T 51501 Ochsner ECC Packs (Material: 709000113). The recall involves Custom Tubing Sets for Extracorporeal Circulation (ECC) with Batch Number 3000060038. 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 sterilization. As a result, the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured, meaning the sterility of the device may be compromised.
Healthcare facilities and users of these specific tubing sets should stop using the affected units and contact Maquet Cardiovascular for further instructions on return or replacement.
The recalled product
- Product
- Maquet Getinge-BEQ-T 51501 Ochsner ECC Pack Material:709000113
- 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: 3000060038
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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