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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device endoscope introducer kit
Definition This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.
Product CodeNWU
Regulation Number 876.1500
Device Class 2

MDR Year MDR Reports MDR Events
2019 1 1
2020 1 1
2021 2 2
2022 2 2
2023 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 1 1
Unsealed Device Packaging 1 1
Particulates 1 1
Material Puncture/Hole 1 1
Problem with Sterilization 1 1
Device Damaged Prior to Use 1 1
Tear, Rip or Hole in Device Packaging 1 1
Connection Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Device Contamination with Chemical or Other Material 1 1
Device Contaminated During Manufacture or Shipping 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5 5
Insufficient Information 3 3
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 American Contract Systems, Inc. II Oct-26-2023
2 American Contract Systems, Inc. II Sep-08-2022
3 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
4 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
5 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
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