Maquet Cardiovascular Recalls Custom Tubing Sets for Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design flaw 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. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects (here, a sterilization failure in a medical device) are rated as Severe (4).
Plain-English summary
Maquet Cardiovascular, LLC is recalling specific batches of Custom Tubing Sets for Extracorporeal Circulation (ECC). The affected products are identified by the following material and batch numbers: Material 701067370R01 (Batch 3000042627), Material 701067370R02 (Batch 3000047034), and Material 701067370R03 (Batch 3000058143). The recall is classified as Class II by the FDA.
The recall is due to a potential defect in the closed stopcock and non-vented cap configuration. During the sterilization process, this 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, meaning the products may not be sterile.
The affected products were distributed nationwide. No specific illnesses or injuries have been reported in the source text. Healthcare facilities and consumers should stop using the affected tubing sets and contact Maquet Cardiovascular for instructions on return or replacement.
The recalled product
- Product
- Maquet Getinge- (1) Material :701067370R01 BO-TOP 38803 OPEN HEART PACK W (2) Material: 701067370R02 BO-TOP 38803 OPEN HEART PACK W (3) Material: 701067370R03 BO-TOP 38803 OPEN HEART PACK W
- 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: (1) 3000042627 (2) 3000047034 (3) 3000058143
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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