Boston Scientific is recalling 806 EndoVive Safety PEG Kits sold nationwide. The recall concerns BD ChloraPrep Triple Swabsticks with open or compromised seals that could compromise sterility or dry the antiseptic solution. Hospitals and patients should stop using the kits immediately and follow the manufacturer's recall instructions.
Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on the sterile swabstick packaging, which could result in loss of sterility or drying of the antiseptic solution. This component is placed outside of the sterile barrier of the tray manufactured by Boston Scientific, which contains the majority of the kit components. As such, inclusion of the affected ChloraPrep Triple Swabsticks does not degrade the integrity of the other components within the PEG kit.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Boston Scientific Corporation or your healthcare provider for instructions. Notification method: Letter
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The EndoVive Safety PEG Kit is used for percutaneous endoscopic gastrostomy procedures. Kits include components to assist after gastrostomy tube placement.
The issue revolves around compromised seals on BD ChloraPrep Triple Swabsticks, which could allow loss of sterility or drying of antiseptic solution, potentially impacting patient safety.
This recall is not described as part of a broader industry pattern in the provided information.
Facilities may experience workflow interruptions and needs to verify the sterility of prepared kits before patient use. The recall could affect procurement and sterilization protocols in hospitals.
Recall notice and detailed instructions are posted on FDA enforcement page linked above.
Refunds or replacements follow the hospital's recall process; typical timelines range from several weeks to a couple of months depending on stock and承
Keep the recall letter, shelf labels, lot numbers, UDIs, and correspondences with the manufacturer. Photograph affected packaging for records.
Quantity: 806 units Brand: Boston Scientific Product: EndoVive Safety PEG Kit UPNs: Outer Box M00509001; Inner Box M00509000 UDIs: Outer Box 08714729880394; Inner Box 08714729880387 Outer Box Lot#: 37435463, 37522541, 37528545, 37546847, 37546850, 37546849, 37550500, 37592036, 37732292 Inner Box Lot#: 37435462, 37514809, 37525231, 37536563, 37536564, 37536562, 37546840 Sold in: United States nationwide Recall date: 2026-02-10 Status: ACTIVE Remedy: Follow manufacturer recall instructions; contact Boston Scientific or healthcare provider for instructions.
No injuries or incidents have been reported.
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