EndoVive PEG kits recalled over compromised ChloraPrep swabstick seals

Plain-English summary

Boston Scientific Corporation is recalling the EndoVive Safety PEG Kit, outer box material number M00509001 and inner box material number M00509000. About 806 units were distributed nationwide in the United States. The FDA has classified this recall as Class II.

The recall covers kits which utilised ChloraPrep Triple Swabsticks from BD. Open or compromised seals on the sterile swabstick packaging could result in loss of sterility or drying of the antiseptic solution. Boston Scientific states that this component is placed outside the sterile barrier of the tray containing the majority of the kit components, so inclusion of the affected swabsticks does not degrade the integrity of the other components within the PEG kit.

Affected product carries outer box UDI 08714729880394 and inner box UDI 08714729880387, across nine outer box lots beginning 37435463 and nine inner box lots beginning 37435462.

Facilities can identify affected kits by the material numbers, UDIs and lot numbers above, and may contact Boston Scientific Corporation for further information.

The recalled product

Product

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

Manufacturer

Boston Scientific Corporation

Category

Medical Device — Enteral feeding

Hazard

• sterility-failure
• seal-compromise
• infection-risk

Affected units

806

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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