Boston Scientific Corporation: EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN): M00509000;

Company / brand

Boston Scientific Corporation

Product

EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN): M00509000;

Reason / 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.

Classification

Class II

Status

Ongoing

Distribution / sold at

US Nationwide distribution.

Recall initiated

2026-02-10

Code info

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;

Product quantity

806 units

Voluntary mandated

Voluntary: Firm initiated

City

Marlborough

State

MA

Country

United States

Event id

98412

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