Maquet Getinge ECC Tubing Sets Recalled Due to 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 involving significant risks or potential for serious injury (such as sterility failure in medical devices) are rated as Severe (4).
Plain-English summary
Maquet Cardiovascular, LLC is recalling Custom Tubing Sets for Extracorporeal Circulation (ECC) with the material number 701051179. The affected products are identified by batch numbers 3000045170, 3000058051, 3000062455, and 3000065508. The recall is classified as Class II by the FDA.
The recall is being issued 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. This issue means that the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured, creating a potential risk of non-sterile components.
The affected products were distributed nationwide. Healthcare facilities and users should stop using the affected tubing sets and contact Maquet Cardiovascular for instructions on how to return or replace the products.
The recalled product
- Product
- Maquet Getinge-BEQ-TOP 22702 ECC W/HMOD 30000 Material: 701051179
- 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: 3000045170 3000058051 3000062455 3000065508
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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