|
Device |
general surgery tray |
Regulation Description |
Surgical drape and drape accessories. |
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 Code | LRO |
Regulation Number |
878.4370
|
Device Class |
2
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
Alcon Research, LLC |
II |
Apr-01-2021 |
2 |
Alcon Research, LLC |
II |
Oct-09-2020 |
3 |
Alcon Research, LTD. |
II |
Aug-25-2017 |
4 |
American Contract Systems |
II |
May-29-2020 |
5 |
Avid Medical, Inc. |
II |
Mar-19-2020 |
6 |
Avid Medical, Inc. |
II |
Feb-28-2018 |
7 |
Avid Medical, Inc. |
II |
Feb-09-2018 |
8 |
Avid Medical, Inc. |
II |
Aug-18-2016 |
9 |
Cardinal Health 200, LLC |
II |
Feb-04-2020 |
10 |
Cardinal Health 200, LLC |
II |
Feb-03-2020 |
11 |
Cardinal Health 200, LLC |
II |
Aug-14-2017 |
12 |
Cardinal Health Inc. |
II |
Jan-09-2019 |
13 |
Centurion Medical Products Corporation |
II |
Feb-05-2020 |
14 |
Centurion Medical Products Corporation |
II |
Nov-06-2019 |
15 |
Centurion Medical Products Corporation |
II |
Oct-31-2019 |
16 |
Covidien LLC |
II |
Nov-08-2016 |
17 |
Custom Assemblies Inc |
II |
Aug-22-2017 |
18 |
Custom Healthcare Systems, Inc. |
II |
Jan-24-2020 |
19 |
Custom Healthcare Systems, Inc. |
II |
Oct-25-2018 |
20 |
Customed, Inc |
II |
Apr-14-2016 |
21 |
DeRoyal Industries Inc |
II |
Feb-19-2021 |
22 |
DeRoyal Industries Inc |
II |
Jul-16-2019 |
23 |
DeRoyal Industries Inc |
II |
Feb-16-2018 |
24 |
DeRoyal Industries Inc |
II |
Jan-12-2018 |
25 |
DeRoyal Industries Inc |
II |
Dec-06-2017 |
26 |
DeRoyal Industries Inc |
III |
Feb-23-2017 |
27 |
DeRoyal Industries Inc |
II |
Aug-26-2016 |
28 |
Deroyal Industries, Inc. Lafollette |
II |
Feb-19-2020 |
29 |
Encore Medical, Lp |
II |
Aug-02-2018 |
30 |
Gi Supply |
II |
Mar-04-2016 |
31 |
Medline Industries Inc |
II |
Jan-07-2021 |
32 |
Medline Industries Inc |
II |
May-15-2020 |
33 |
Medline Industries Inc |
II |
Mar-20-2020 |
34 |
ROi CPS LLC |
II |
Jan-30-2020 |
35 |
Resource Optimization & Innovation Llc |
II |
Nov-21-2017 |
36 |
Resource Optimization & Innovation Llc |
II |
Mar-24-2017 |
37 |
Stryker GmbH |
II |
Mar-06-2019 |
38 |
Windstone Medical Packaging, Inc. |
II |
Nov-07-2017 |
39 |
Wright Medical Technology, Inc. |
II |
Aug-13-2020 |
|
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