[pending] EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UP
Pending LLM rewrite. Source: FDA_DEVICE Z-1551-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
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 — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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