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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device hood, surgical
Regulation Description Surgical apparel.
Product CodeFXY
Regulation Number 878.4040
Device Class 2


Premarket Reviews
ManufacturerDecision
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
THI TOTAL HEALTHCARE INNOVATION GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 1 1
2021 1 1
2022 2 2
2023 6 11
2024 11 13
2025 7 8

Device Problems MDRs with this Device Problem Events in those MDRs
Device Contaminated During Manufacture or Shipping 12 15
Delivered as Unsterile Product 10 16
Device Contamination with Chemical or Other Material 5 5
Material Frayed 1 1
Material Puncture/Hole 1 1
Material Integrity Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 25 31
Insufficient Information 2 4
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 O&M HALYARD, INC. III Apr-02-2024
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