Boston Scientific EndoVive Safety PEG Kit recalled for compromised antiseptic swabstick packaging
Boston Scientific is recalling certain EndoVive Safety PEG Kits that contain ChloraPrep Triple Swabsticks with open or damaged packaging. The affected swabsticks may have lost sterility or dried out. The rest of the kit components remain safe and unaffected.
From the FDA notice · Read the official notice ↗ · All Boston Scientific recalls
What to do
- Check if your kit matches one of the recalled lot numbers listed in the notice
- Do not use the included ChloraPrep Triple Swabstick if packaging is open or compromised
- Contact Boston Scientific or your distributor for a replacement or instructions
- Consult your healthcare provider if you have already used an affected kit
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN): M00509000;
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
Details
- Units affected
- 806 units
- Illnesses reported
- None reported
- Manufactured in
- 100 Boston Scientific Way, N/A, Marlborough, MA, United States
- Classification
- Class II
- Recall number
- Z-1551-2026
In the FDA's words
- Description
- EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN): M00509000; 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. Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN): M00509000; Outer Box UDI: 08714729880394; Inner Box UDI: 08714729880387; Outer Box Lot#s: 37435463, 37522541, 37528545, 37546847, 37546850, 37546849, 37550500, 37592036, 37732292; Inner Box Lot#s: 37435462, 37514809, 37525231, 37536563, 37536564, 37536562, 37546840, 37583642, 37731897; Distribution: US Nationwide distribution. Affected quantity: 806 units
- Hazard
- 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.
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