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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device laceration tray
Regulation Description Nonresorbable gauze/sponge for external use.
Definition This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Product CodePKD
Regulation Number 878.4014
Device Class 1

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield II Dec-30-2024
2 MEDLINE INDUSTRIES, LP - Northfield II Dec-05-2024
3 MEDLINE INDUSTRIES, LP - Northfield II Oct-23-2024
4 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
5 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
6 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
7 Medline Industries, LP II May-07-2026
8 Medline Industries, LP II Apr-30-2026
9 Medline Industries, LP II Feb-17-2026
10 Medline Industries, LP II Feb-09-2026
11 Stradis Healthcare II Jan-11-2023
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