|
Device |
pump, infusion |
Product Code | FRN |
Regulation Number |
880.5725
|
Device Class |
2
|
MDR Year |
MDR Reports |
MDR Events |
2017 |
12059 |
12059 |
2018 |
16585 |
16585 |
2019 |
15857 |
15857 |
2020 |
94219 |
94219 |
2021 |
199381 |
199381 |
2022 |
506760 |
506760 |
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
Baxter Healthcare Corporation |
I |
Jan-29-2022 |
2 |
Baxter Healthcare Corporation |
I |
Aug-11-2021 |
3 |
Baxter Healthcare Corporation |
I |
Aug-06-2021 |
4 |
Baxter Healthcare Corporation |
II |
Apr-23-2021 |
5 |
Baxter Healthcare Corporation |
II |
Feb-25-2021 |
6 |
Baxter Healthcare Corporation |
II |
Dec-23-2020 |
7 |
Baxter Healthcare Corporation |
I |
Oct-22-2020 |
8 |
Baxter Healthcare Corporation |
II |
May-02-2019 |
9 |
Baxter Healthcare Corporation |
II |
Jun-07-2018 |
10 |
Baxter Healthcare Corporation |
II |
May-04-2018 |
11 |
Baxter Healthcare Corporation |
II |
Mar-12-2018 |
12 |
Baxter Healthcare Corporation |
II |
Oct-02-2017 |
13 |
Bayer Healthcare |
II |
Feb-08-2017 |
14 |
BioMedical Equipment Service Co (BMES) |
I |
Aug-06-2021 |
15 |
CME America LLC |
II |
Oct-29-2020 |
16 |
CME America, LLC |
II |
Dec-03-2020 |
17 |
CME America, LLC |
I |
Mar-18-2020 |
18 |
CME America, LLC |
I |
Mar-11-2020 |
19 |
CareFusion 303, Inc. |
I |
Apr-01-2021 |
20 |
CareFusion 303, Inc. |
I |
Sep-12-2020 |
21 |
CareFusion 303, Inc. |
I |
Sep-04-2020 |
22 |
CareFusion 303, Inc. |
I |
Sep-04-2020 |
23 |
CareFusion 303, Inc. |
II |
Aug-19-2020 |
24 |
CareFusion 303, Inc. |
I |
Aug-06-2020 |
25 |
CareFusion 303, Inc. |
I |
Aug-06-2020 |
26 |
CareFusion 303, Inc. |
I |
Aug-06-2020 |
27 |
CareFusion 303, Inc. |
I |
Mar-05-2020 |
28 |
CareFusion 303, Inc. |
I |
Jul-16-2019 |
29 |
CareFusion 303, Inc. |
II |
Jan-08-2018 |
30 |
CareFusion 303, Inc. |
II |
Oct-19-2017 |
31 |
CareFusion 303, Inc. |
II |
Jun-19-2017 |
32 |
CareFusion 303, Inc. |
II |
Jun-19-2017 |
33 |
CareFusion 303, Inc. |
II |
Mar-21-2017 |
34 |
CareFusion 303, Inc. |
I |
Jan-18-2017 |
35 |
Fenwal Inc |
I |
Aug-12-2019 |
36 |
Fresenius Vial Sa |
II |
Nov-02-2018 |
37 |
Hospira Inc., A Pfizer Company |
II |
Mar-24-2017 |
38 |
ICU |
II |
Jul-07-2017 |
39 |
ICU Medical Inc |
II |
Oct-22-2019 |
40 |
ICU Medical Inc |
II |
Oct-14-2019 |
41 |
ICU Medical Inc |
II |
Dec-06-2017 |
42 |
ICU Medical Inc |
II |
Nov-16-2017 |
43 |
ICU Medical Inc |
II |
Aug-14-2017 |
44 |
InfuTronix LLC |
II |
Mar-29-2022 |
45 |
InfuTronix LLC |
II |
Jul-23-2019 |
46 |
Infusion Pump Repair |
I |
May-10-2021 |
47 |
Pacific Medical Group Inc. |
I |
Apr-19-2021 |
48 |
Repro-Med Systems, Inc. |
II |
Jan-05-2018 |
49 |
STEP-HAR MEDICAL LLC |
I |
May-10-2021 |
50 |
Smiths Medical ASD Inc. |
II |
Feb-17-2022 |
51 |
Smiths Medical ASD Inc. |
I |
Oct-19-2021 |
52 |
Smiths Medical ASD Inc. |
I |
Aug-06-2020 |
53 |
Smiths Medical ASD Inc. |
I |
Dec-12-2019 |
54 |
Smiths Medical ASD Inc. |
II |
Aug-08-2018 |
55 |
Smiths Medical ASD Inc. |
II |
Mar-05-2018 |
56 |
Smiths Medical ASD Inc. |
II |
Jan-04-2018 |
57 |
Smiths Medical ASD Inc. |
II |
Jan-02-2018 |
58 |
Smiths Medical ASD Inc. |
II |
Nov-01-2017 |
59 |
Smiths Medical ASD Inc. |
II |
Aug-25-2017 |
60 |
Tenacore LLC |
I |
Apr-02-2021 |
61 |
The Biomed Guys |
I |
Jun-01-2021 |
62 |
WalkMed, LLC |
II |
Nov-13-2017 |
63 |
Zevex Incorporated (dba MOOG Medical Devices Group) |
II |
Jul-23-2019 |
|
|
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