Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device central venous catheter tray
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 CodeOFF
Regulation Number 870.1140
Device Class 2

MDR Year MDR Reports MDR Events
2019 2 2
2020 1 1
2021 4 4
2022 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1 1
Crack 1 1
Difficult to Remove 1 1
Microbial Contamination of Device 1 1
Component Missing 1 1
Difficult to Advance 1 1
Difficult to Open or Remove Packaging Material 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Twisted/Bent 1 1
Output Problem 1 1
Packaging Problem 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Bacterial Infection 1 1
Viral Infection 1 1
No Patient Involvement 1 1
No Known Impact Or Consequence To Patient 1 1
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 American Contract Systems, Inc. II Sep-08-2022
2 Centurion Medical Products Corporation II Feb-05-2020
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-10-2023
6 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
7 MEDLINE INDUSTRIES, LP - Northfield II Oct-13-2022
8 MEDLINE INDUSTRIES, LP - SPT II Jul-27-2022
9 Medical Action Industries, Inc. 306 II Nov-18-2022
10 Medical Action Industries, Inc. 306 I May-12-2021
11 Medline Industries Inc II Dec-10-2021
12 Medline Industries, Inc. II Jul-06-2018
13 Resource Optimization & Innovation LLC II Jun-15-2020
14 Stradis Healthcare II Jan-11-2023
-
-