Maquet Pediatric ECC Tubing Sets Recalled for Sterility Assurance Concerns
Maquet Cardiovascular is recalling Pediatric ECC Packs because a design feature may prevent sterilization gas from reaching all fluid paths, compromising sterility.
What this means for you
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 risk-of-harm product (sterility failure in a medical device) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Maquet Cardiovascular, LLC is recalling the Maquet Getinge-BEQ-TOP 7005 UAMC Pediatric ECC Pack (Material: 701051515). The recall involves Custom Tubing Sets for Extracorporeal Circulation (ECC) distributed nationwide. The affected batch numbers are 3000041127, 3000049458, 3000061103, 3000065550, 3000071378, 3000075338, and 3000081601.
The recall was initiated because the closed stopcock/non-vented cap configuration may prevent the flow of humidity and ethylene oxide gas into the fluid path between the closed port and the non-vented cap during sterilization. As a result, the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured.
Healthcare facilities and distributors should identify and quarantine the affected units. The source text does not specify a specific consumer action for the general public, as these are medical devices intended for professional use.
The recalled product
- Product
- Maquet Getinge-BEQ-TOP 7005 UAMC Pediatric ECC Pack Material: 701051515
- Manufacturer
- Maquet Cardiovascular, LLC
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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