Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design flaw may prevent proper sterilization of the stopcock ports.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 hazard involves the potential use of non-sterile medical devices in a critical surgical setting (extracorporeal circulation), which poses a significant risk of serious injury or infection.
Plain-English summary
Maquet Cardiovascular, LLC is recalling Maquet Getinge-BO-TOP 20705 SMALL PATIENT 1/4 Custom Tubing Sets for Extracorporeal Circulation (ECC). The affected units are identified by Material 701053486 and specific batch numbers: 3000048716, 3000054549, 3000061302, 3000067224, 3000070815, 3000072509, and 3000076464. The recall is classified as Class II by the FDA.
The recall is due to a potential sterilization failure. During the sterilization process, the closed stopcock and non-vented cap configuration may prevent the flow of humidity and ethylene oxide gas into the fluid path between the closed port and the cap. As a result, the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured, which could lead to the use of non-sterile medical devices.
The affected products were distributed nationwide. Healthcare facilities and users should stop using the affected tubing sets and contact Maquet Cardiovascular for further instructions or replacement.
The recalled product
- Product
- Maquet Getinge-BO-TOP 20705 SMALL PATIENT 1/4 Material: 701053486
- Manufacturer
- Maquet Cardiovascular, LLC
- Category
- Medical Device — Surgical Tubing
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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