Boston Scientific Corporation is recalling 806 EndoVive Safety PEG Kits because the included ChloraPrep Triple Swabsticks may have open or compromised sterile seals. This defect can lead to the loss of sterility or the drying out of the antiseptic solution within the swabsticks. While the swabsticks are packaged outside the main sterile tray and do not affect the integrity of other kit components, using non-sterile or dried antiseptic could compromise patient safety during medical procedures.
Compromised seals on the antiseptic swabsticks can result in a loss of sterility or reduced effectiveness of the solution, potentially increasing the risk of infection at the procedure site.
Recall involves ChloraPrep Triple Swabsticks from BD included within the kit; the swabsticks are outside the sterile barrier of the main tray.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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