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.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the rubric specifies that FDA Class II recalls with potential for significant injury or hospitalization (implied by the loss of sterility assurance in a critical medical device) fall under the 'Severe' category.
Plain-English summary
Maquet Cardiovascular, LLC is recalling specific custom tubing sets for extracorporeal circulation (ECC) manufactured by Maquet Getinge. The affected products are identified by the material code 701064560R01 and specific batch numbers: 3000068115, 3000081002, and 3000083490. The recall is classified as Class II by the U.S. Food and Drug Administration.
The recall is issued because the closed stopcock and non-vented cap configuration on these devices may prevent the flow of humidity and ethylene oxide gas into the fluid path during the sterilization process. This issue means that the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured, creating a potential risk of non-sterile components being used in medical procedures.
The affected products were distributed nationwide. Healthcare facilities and consumers who have these specific tubing sets should stop using them and contact Maquet Cardiovascular, LLC for instructions on how to return or replace the products. No specific dates or additional distribution details are provided in the source text.
The recalled product
- Product
- Maquet Getinge- BEQ-T 5211 ECC Large Children's Hospital Material: 701064560R01
- 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: 3000068115 3000081002 3000083490
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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