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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device first aid kit with drug
Definition Note: In addition to compliance with our convenience kit guidance, in regards to any drug products contained in this kit compliance with the Center for Drug Evaluation is required as well. www.fda.gov/cder/index.html - 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 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 CodeLRR
Device Class Not Classified

MDR Year MDR Reports MDR Events
2022 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Blister 1 1
No Clinical Signs, Symptoms or Conditions 1 1

Recalls
Manufacturer Recall Class Date Posted
1 ASO LLC II May-04-2022
2 Certified Safety Mfg Inc II May-11-2022
3 Family Dollar Stores, Llc. II Aug-17-2022
4 HF Acquisition Co. LLC II Aug-10-2020
5 HF Acquisition Co., LLC II Aug-12-2020
6 Total Resources Intl II May-13-2022
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