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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device anesthesia 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 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 CodeOFQ
Regulation Number 868.5120
Device Class 2

MDR Year MDR Reports MDR Events
2020 1 1
2021 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 1 1
Failure to Deliver 1 1
Device Contamination with Chemical or Other Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 1 1
No Known Impact Or Consequence To Patient 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 American Contract Systems, Inc. II Jan-26-2024
2 Cardinal Health 200, LLC II Oct-10-2023
3 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
4 Stradis Medical, LLC dba Stradis Healthcare II Apr-04-2022
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