EndoVive PEG kits recalled over compromised ChloraPrep swabstick seals
Boston Scientific is recalling EndoVive Safety PEG Kits containing BD ChloraPrep Triple Swabsticks because open or compromised seals on the swabstick packaging could cause loss of sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: a compromised seal may leave the antiseptic non-sterile or dried out, and no injuries are stated in the source.
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
- 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.
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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