| | Class 2 Device Recall Single Luman Conserver |  |
| Date Initiated by Firm | April 26, 2019 |
|---|
| Create Date | July 29, 2019 |
|---|
| Recall Status1 |
Terminated 3 on April 02, 2021 |
| Recall Number | Z-2099-2019 |
|---|
| Recall Event ID |
82793 |
| 510(K)Number | K060751 |
|---|
| Product Classification |
Conserver, oxygen - Product Code NFB
|
| Product | Inovo Single Luman Conserver
Product Usage:
This device is intended to regulate the flow of oxygen from an oxygen tank and only deliver oxygen as the patient inhales, resulting in greater efficiency and cost saving ratios. |
|---|
| Code Information |
SERIAL NUMBERS BY MODELS: C0019802 IN6505-L-Blue C0019803 IN6505-L-Blue C0019804 IN6505-L-Blue C0019805 IN6505-L-Blue C0019806 IN6505-L-Blue C0019808 IN6505-L-Blue C0019820 IN6505-L-Blue C0019825 IN6505-L-Blue C0019826 IN6505-L-Blue C0019827 IN6505-L-Blue C0019828 IN6505-L-Blue C0019831 IN6505-L-Blue C0019833 IN6505-L-Blue C0019834 IN6505-L-Blue C0019874 IN6505-L-Blue C0019894 IN6505-L-Blue C0019895 IN6505-L-Blue C0019899 IN6505-L-Blue C0019917 IN6505-L-Blue C0019918 IN6505-L-Blue C0019884 IN6505-L-Blue C0019889 IN6505-L-Blue C0019893 IN6505-L-Blue C0019897 IN6505-L-Blue C0019910 IN6505-L-Blue C0019911 IN6505-L-Blue C0019913 IN6505-L-Blue C0019914 IN6505-L-Blue C0020421 IN6505-L-Blue C0019807 IN6505-L-Blue C0019818 IN6505-L-Blue C0019832 IN6505-L-Blue C0019836 IN6505-L-Blue C0019837 IN6505-L-Blue C0019838 IN6505-L-Blue C0019873 IN6505-L-Blue C0019883 IN6505-L-Blue C0019892 IN6505-L-Blue C0019896 IN6505-L-Blue C0019903 IN6505-L-Blue C0019909 IN6505-L-Blue C0019916 IN6505-L-Blue C0020405 IN6505-L-Blue C0020416 IN6505-L-Blue C0020417 IN6505-L-Blue C0020431 IN6505-L-Blue C0020432 IN6505-L-Blue C0019890 IN6505-L-Blue C0019891 IN6505-L-Blue C0019912 IN6505-L-Blue C0019915 IN6505-L-Blue C0020407 IN6505-L-Blue C0020410 IN6505-L-Blue C0020414 IN6505-L-Blue C0020418 IN6505-L-Blue C0019854 IN6505-L-Blue C0020406 IN6505-L-Blue C0020411 IN6505-L-Blue C0019864 IN6505-L-Blue C0019868 IN6505-L-Blue C0019877 IN6505-L-Blue C0019879 IN6505-L-Blue C0019882 IN6505-L-Blue C0019886 IN6505-L-Blue C0020419 IN6505-L-Blue C0020423 IN6505-L-Blue C0020426 IN6505-L-Blue C0020429 IN6505-L-Blue C0020430 IN6505-L-Blue C0020433 IN6505-L-Blue C0019853 IN6505-L-Blue C0019867 IN6505-L-Blue C0019870 IN6505-L-Blue C0019876 IN6505-L-Blue C0019880 IN6505-L-Blue C0019888 IN6505-L-Blue C0019801 IN6505-L-Blue C0019817 IN6505-L-Blue C0019829 IN6505-L-Blue C0019830 IN6505-L-Blue C0019835 IN6505-L-Blue C0020408 IN6505-L-Blue C0020409 IN6505-L-Blue C0020412 IN6505-L-Blue C0020413 IN6505-L-Blue C0020415 IN6505-L-Blue C0020428 IN6505-L-Blue C0020427 IN6505-L-Blue C0019851 IN6505-L-Blue C0019852 IN6505-L-Blue C0019865 IN6505-L-Blue C0019866 IN6505-L-Blue C0019869 IN6505-L-Blue C0019871 IN6505-L-Blue C0019872 IN6505-L-Blue C0019875 IN6505-L-Blue C0019878 IN6505-L-Blue C0019881 IN6505-L-Blue C0019885 IN6505-L-Blue C0019887 IN6505-L-Blue C0020045 IN6505-L-Blue C0020046 IN6505-L-Blue C0020047 IN6505-L-Blue C0020048 IN6505-L-Blue C0020049 IN6505-L-Blue C0020050 IN6505-L-Blue C0020053 IN6505-L-Blue C0020054 IN6505-L-Blue C0020055 IN6505-L-Blue C0020056 IN6505-L-Blue C0020059 IN6505-L-Blue C0020062 IN6505-L-Blue C0020063 IN6505-L-Blue C0020218 IN6505-L-Blue C0020219 IN6505-L-Blue C0020221 IN6505-L-Blue C0020222 IN6505-L-Blue C0020223 IN6505-L-Blue C0020224 IN6505-L-Blue C0020229 IN6505-L-Blue C0020230 IN6505-L-Blue C0020231 IN6505-L-Blue C0020232 IN6505-L-Blue C0020235 IN6505-L-Blue C0020239 IN6505-L-Blue C0020240 IN6505-L-Blue C0020245 IN6505-L-Blue C0020246 IN6505-L-Blue C0020247 IN6505-L-Blue C0020248 IN6505-L-Blue C0020251 IN6505-L-Blue C0020261 IN6505-L-Blue C0020265 IN6505-L-Blue C0020268 IN6505-L-Blue C0020269 IN6505-L-Blue C0020270 IN6505-L-Blue C0020271 IN6505-L-Blue C0020272 IN6505-L-Blue C0020280 IN6505-L-Blue C0020283 IN6505-L-Blue C0020284 IN6505-L-Blue C0020286 IN6505-L-Blue C0020289 IN6505-L-Blue C0020290 IN6505-L-Blue C0020297 IN6505-L-Blue C0019819 IN6505-L-Blue C0019821 IN6505-L-Blue C0019822 IN6505-L-Blue C0019823 IN6505-L-Blue C0019824 IN6505-L-Blue C0019839 IN6505-L-Blue C0019840 IN6505-L-Blue C0019841 IN6505-L-Blue C0019842 IN6505-L-Blue C0019843 IN6505-L-Blue C0019844 IN6505-L-Blue C0019845 IN6505-L-Blue C0019846 IN6505-L-Blue C0019847 IN6505-L-Blue C0019848 IN6505-L-Blue C0019849 IN6505-L-Blue C0019855 IN6505-L-Blue C0019856 IN6505-L-Blue C0019857 IN6505-L-Blue C0019858 IN6505-L-Blue C0019859 IN6505-L-Blue C0019860 IN6505-L-Blue C0019861 IN6505-L-Blue C0019862 IN6505-L-Blue C0019863 IN6505-L-Blue C0019900 IN6505-L-Blue C0019902 IN6505-L-Blue C0019908 IN6505-L-Blue C0019920 IN6505-L-Blue C0019921 IN6505-L-Blue C0020258 IN6505-L-Blue C0020259 IN6505-L-Blue C0020260 IN6505-L-Blue C0020266 IN6505-L-Blue C0020267 IN6505-L-Blue C0020420 IN6505-L-Blue C0020422 IN6505-L-Blue C0020424 IN6505-L-Blue C0020425 IN6505-L-Blue C0020434 IN6505-L-Blue C0019450 ML6505-L C0019997 ML6505-L C0019999 ML6505-L C0020000 ML6505-L C0020001 ML6505-L C0020002 ML6505-L C0020003 ML6505-L C0020005 ML6505-L C0020006 ML6505-L C0020009 ML6505-L C0020012 ML6505-L C0020013 ML6505-L C0020014 ML6505-L C0020015 ML6505-L C0020016 ML6505-L C0020017 ML6505-L C0020018 ML6505-L C0020019 ML6505-L C0020020 ML6505-L C0020021 ML6505-L C0020024 ML6505-L C0020025 ML6505-L C0020026 ML6505-L C0020027 ML6505-L C0020028 ML6505-L C0020029 ML6505-L C0019459 ML6505-L C0019463 ML6505-L C0019469 ML6505-L C0019472 ML6505-L C0019760 ML6505-L C0019922 ML6505-L C0019926 ML6505-L C0019927 ML6505-L C0019934 ML6505-L C0019938 ML6505-L C0019941 ML6505-L C0019944 ML6505-L C0019945 ML6505-L C0019949 ML6505-L C0019951 ML6505-L C0019954 ML6505-L C0019955 ML6505-L C0019957 ML6505-L C0019958 ML6505-L C0019959 ML6505-L C0019960 ML6505-L C0019961 ML6505-L C0019962 ML6505-L C0019963 ML6505-L C0019964 ML6505-L C0019965 ML6505-L C0019966 ML6505-L C0019967 ML6505-L C0019968 ML6505-L C0019969 ML6505-L C0019970 ML6505-L C0019971 ML6505-L C0019972 ML6505-L C0019973 ML6505-L C0019974 ML6505-L C0019975 ML6505-L C0019976 ML6505-L C0019977 ML6505-L C0019978 ML6505-L C0019979 ML6505-L C0019980 ML6505-L C0019981 ML6505-L C0019982 ML6505-L C0019983 ML6505-L C0019984 ML6505-L C0019985 ML6505-L C0019986 ML6505-L C0019987 ML6505-L C0019988 ML6505-L C0019989 ML6505-L C0019990 ML6505-L C0019991 ML6505-L C0019992 ML6505-L C0019993 ML6505-L C0019994 ML6505-L C0019995 ML6505-L C0019996 ML6505-L C0020030 ML6505-L C0020031 ML6505-L C0020032 ML6505-L C0020033 ML6505-L C0020034 ML6505-L C0020035 ML6505-L C0020036 ML6505-L C0020037 ML6505-L C0019448 ML6505-L C0019454 ML6505-L C0019458 ML6505-L C0019754 ML6505-L C0019769 ML6505-L C0019901 ML6505-L C0019906 ML6505-L C0019907 ML6505-L C0019923 ML6505-L C0019935 ML6505-L C0019950 ML6505-L C0019457 ML6505-L C0019471 ML6505-L C0019762 ML6505-L C0019767 ML6505-L C0019942 ML6505-L C0019998 ML6505-L C0020007 ML6505-L C0020010 ML6505-L C0020011 ML6505-L C0019412 ML6505-L C0019413 ML6505-L C0019414 ML6505-L C0019416 ML6505-L C0019421 ML6505-L C0019422 ML6505-L C0019424 ML6505-L C0019425 ML6505-L C0019434 ML6505-L C0019445 ML6505-L C0019446 ML6505-L C0019447 ML6505-L C0019449 ML6505-L C0019452 ML6505-L C0019460 ML6505-L C0019461 ML6505-L C0019462 ML6505-L C0019464 ML6505-L C0019465 ML6505-L C0019466 ML6505-L C0019467 ML6505-L C0019468 ML6505-L C0019470 ML6505-L C0019473 ML6505-L C0019474 ML6505-L C0019475 ML6505-L C0019476 ML6505-L C0019477 ML6505-L C0019478 ML6505-L C0019479 ML6505-L C0019480 ML6505-L C0019481 ML6505-L C0019482 ML6505-L C0019483 ML6505-L C0019485 ML6505-L C0019487 ML6505-L C0019488 ML6505-L C0019489 ML6505-L C0019490 ML6505-L C0019491 ML6505-L C0019492 ML6505-L C0019493 ML6505-L C0019494 ML6505-L C0019495 ML6505-L C0019496 ML6505-L C0019497 ML6505-L C0019498 ML6505-L C0019499 ML6505-L C0019500 ML6505-L C0019501 ML6505-L C0019502 ML6505-L C0019508 ML6505-L C0019509 ML6505-L C0019510 ML6505-L C0019511 ML6505-L C0019512 ML6505-L C0019513 ML6505-L C0019514 ML6505-L C0019515 ML6505-L C0019516 ML6505-L C0019746 ML6505-L C0019756 ML6505-L C0019758 ML6505-L C0019781 ML6505-L C0019782 ML6505-L C0019783 ML6505-L C0019784 ML6505-L C0019415 ML6505-L C0019418 ML6505-L C0019427 ML6505-L C0019428 ML6505-L C0019429 ML6505-L C0019430 ML6505-L C0019433 ML6505-L C0019435 ML6505-L
C0019436 ML6505-L C0019437 ML6505-L C0019438 ML6505-L C0019439 ML6505-L C0019440 ML6505-L C0019441 ML6505-L C0019442 ML6505-L C0019443 ML6505-L C0019451 ML6505-L C0019453 ML6505-L C0019455 ML6505-L C0019456 ML6505-L C0019766 ML6505-L C0019785 ML6505-L C0019786 ML6505-L C0019787 ML6505-L C0019788 ML6505-L C0019789 ML6505-L C0019790 ML6505-L C0019791 ML6505-L C0019792 ML6505-L C0019793 ML6505-L C0019794 ML6505-L C0019795 ML6505-L C0019796 ML6505-L C0019800 ML6505-L C0019809 ML6505-L C0019810 ML6505-L C0019811 ML6505-L C0019812 ML6505-L C0019815 ML6505-L C0019816 ML6505-L C0020022 ML6505-L C0020023 ML6505-L C0019417 ML6505-L C0019423 ML6505-L C0019503 ML6505-L C0019504 ML6505-L C0019505 ML6505-L C0019506 ML6505-L C0019507 ML6505-L C0019745 ML6505-L C0019748 ML6505-L C0019751 ML6505-L C0019757 ML6505-L C0019764 ML6505-L C0019768 ML6505-L C0019770 ML6505-L C0019772 ML6505-L C0019773 ML6505-L C0019774 ML6505-L C0019780 ML6505-L C0020008 ML6505-L C0019419 ML6505-L C0019420 ML6505-L C0019426 ML6505-L C0019431 ML6505-L C0019432 ML6505-L C0019444 ML6505-L C0019484 ML6505-L C0019486 ML6505-L C0019797 ML6505-L C0019798 ML6505-L C0019799 ML6505-L C0019813 ML6505-L C0019814 ML6505-L C0019898 ML6505-L C0019904 ML6505-L C0019905 ML6505-L C0019919 ML6505-L C0019924 ML6505-L C0019925 ML6505-L C0019928 ML6505-L C0019929 ML6505-L C0019930 ML6505-L C0019931 ML6505-L C0019932 ML6505-L C0019933 ML6505-L C0019936 ML6505-L C0019937 ML6505-L C0019939 ML6505-L C0019940 ML6505-L C0019943 ML6505-L C0019946 ML6505-L C0019947 ML6505-L C0019948 ML6505-L C0019952 ML6505-L C0019953 ML6505-L C0019747 ML6505-L C0019749 ML6505-L C0019750 ML6505-L C0019752 ML6505-L C0019753 ML6505-L C0019755 ML6505-L C0019759 ML6505-L C0019761 ML6505-L C0019763 ML6505-L C0019765 ML6505-L C0019771 ML6505-L C0019775 ML6505-L C0019776 ML6505-L C0019777 ML6505-L C0019778 ML6505-L C0019779 ML6505-L C0019385 R6505-L C0019386 R6505-L C0019387 R6505-L C0019388 R6505-L C0019389 R6505-L C0019390 R6505-L C0019391 R6505-L C0019392 R6505-L C0019393 R6505-L C0019394 R6505-L C0019395 R6505-L C0019396 R6505-L C0019397 R6505-L C0019398 R6505-L C0019399 R6505-L C0019400 R6505-L C0019401 R6505-L C0019402 R6505-L C0019403 R6505-L C0019404 R6505-L C0019405 R6505-L C0019406 R6505-L C0019407 R6505-L C0019408 R6505-L C0019409 R6505-L C0019410 R6505-L C0019518 R6505-L C0019519 R6505-L C0019520 R6505-L C0019521 R6505-L C0019522 R6505-L C0019523 R6505-L C0019524 R6505-L C0019525 R6505-L C0019526 R6505-L C0019527 R6505-L C0019528 R6505-L C0019529 R6505-L C0019530 R6505-L C0019531 R6505-L C0019532 R6505-L C0019533 R6505-L C0019534 R6505-L C0019535 R6505-L C0019536 R6505-L C0019537 R6505-L C0019538 R6505-L C0019539 R6505-L C0019540 R6505-L C0019541 R6505-L C0019542 R6505-L C0019543 R6505-L C0019544 R6505-L C0019545 R6505-L C0019546 R6505-L C0019547 R6505-L C0019548 R6505-L C0019549 R6505-L C0019550 R6505-L C0019551 R6505-L C0019552 R6505-L C0019553 R6505-L C0019554 R6505-L C0019555 R6505-L C0019556 R6505-L C0019557 R6505-L C0019558 R6505-L C0019559 R6505-L C0019560 R6505-L C0019561 R6505-L C0019562 R6505-L C0019563 R6505-L C0019564 R6505-L C0019565 R6505-L C0019566 R6505-L C0019567 R6505-L C0019568 R6505-L C0019569 R6505-L C0019570 R6505-L C0019571 R6505-L C0019572 R6505-L C0019573 R6505-L C0019574 R6505-L C0019575 R6505-L C0019576 R6505-L C0019577 R6505-L C0019578 R6505-L C0019579 R6505-L C0019580 R6505-L C0019581 R6505-L C0019582 R6505-L C0019583 R6505-L C0019584 R6505-L C0019585 R6505-L C0019586 R6505-L C0019587 R6505-L C0019588 R6505-L C0019589 R6505-L C0019590 R6505-L C0019591 R6505-L C0019592 R6505-L C0019593 R6505-L C0019594 R6505-L C0019595 R6505-L C0019596 R6505-L C0019597 R6505-L C0019598 R6505-L C0019599 R6505-L C0019600 R6505-L C0019601 R6505-L C0019602 R6505-L C0019603 R6505-L C0019604 R6505-L C0019605 R6505-L C0019606 R6505-L C0019607 R6505-L C0019608 R6505-L C0019609 R6505-L C0019610 R6505-L C0019611 R6505-L C0019612 R6505-L C0019613 R6505-L C0019614 R6505-L C0019615 R6505-L C0019616 R6505-L C0019617 R6505-L C0019618 R6505-L C0019619 R6505-L C0019620 R6505-L C0019621 R6505-L C0019622 R6505-L C0020065 R6505-L C0020066 R6505-L C0020067 R6505-L C0020068 R6505-L C0020069 R6505-L C0020070 R6505-L C0020071 R6505-L C0020145 R6505-L C0020146 R6505-L C0020147 R6505-L C0020148 R6505-L C0020149 R6505-L C0020150 R6505-L C0020151 R6505-L C0020152 R6505-L C0020153 R6505-L C0020154 R6505-L C0020155 R6505-L C0020156 R6505-L C0020157 R6505-L C0020158 R6505-L C0020159 R6505-L C0020160 R6505-L C0020161 R6505-L C0020162 R6505-L C0020163 R6505-L C0020164 R6505-L C0020165 R6505-L C0020166 R6505-L C0020167 R6505-L C0020168 R6505-L C0020169 R6505-L C0020170 R6505-L C0020171 R6505-L C0020172 R6505-L C0020173 R6505-L C0020174 R6505-L C0020175 R6505-L C0020176 R6505-L C0020177 R6505-L C0020178 R6505-L C0020179 R6505-L C0020180 R6505-L C0020181 R6505-L C0020182 R6505-L C0020183 R6505-L C0020184 R6505-L C0020185 R6505-L C0020186 R6505-L C0020187 R6505-L C0020188 R6505-L C0020189 R6505-L C0020190 R6505-L C0020191 R6505-L C0020192 R6505-L C0020193 R6505-L C0020194 R6505-L C0020195 R6505-L C0020196 R6505-L C0020197 R6505-L C0020198 R6505-L C0020199 R6505-L C0020200 R6505-L C0020201 R6505-L C0020202 R6505-L C0020203 R6505-L C0020204 R6505-L C0020205 R6505-L C0020206 R6505-L C0020207 R6505-L C0020208 R6505-L C0020209 R6505-L C0020210 R6505-L C0020211 R6505-L C0020212 R6505-L C0020213 R6505-L C0020214 R6505-L C0020215 R6505-L and C0020216 R6505-L |
Recalling Firm/
Manufacturer |
Inovo, Inc
401 Leonard Blvd N
Lehigh Acres FL 33971-6302
|
| For Additional Information Contact | Patricia Beja
877-224-0946 Ext. 4282 |
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Manufacturer Reason
for Recall | The pressure gauge (manometer) may dislodge from the threaded insertion/mount, creating a leak. |
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FDA Determined
Cause 2 | Process control |
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| Action | On April 26, 2019 INOVO sent a recall communication to all their customer with the following instructions:
What actions are required?
1) If the product was further distributed, please:
a. post this notice in a manner most likely to come to the attention of
those customers;
b. if possible, directly notify those customers of this voluntary field
action and send them a copy of this notice; and
c. instruct any and all customers in possession of the products to
discontinue use immediately.
2) Quarantine any stock that is still in your current inventory.
3) Return any stock to Inovo, Inc. Inovo will supply return shipping labels as
requested.
4) Please sign and date the accompanying acknowledgement form upon
receipt. Please scan and send the signed form to the Inovo, Inc. Recall
coordinator, Patricia Beja, at FieldAction@drivemedical.com or return it in
the self-addressed stamped envelope provided.
5) To obtain a replacement for any returned conservers please return the
Recall Acknowledgement paperwork.
6) Please forward your internal Recall protocols for our records.
Will replacement product be available?
Replacements will be made as inventory is available. We are offering as
replacement new unit or the Bonsai OM-812. We will expedite consumer
replacements as required.
If you have any questions concerning these instructions, please email Inovo, Inc. Recall coordinator Patricia Beja at FieldAction@drivemedical.com. For urgent assistance, please call 1-877-224-0946, ext. 4282. |
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| Quantity in Commerce | 690 |
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| Distribution | US Nationwide Distribution - AZ, CO, FL, GA, IL, LA, MI, MO, MT, NY, SC, TX, and UT |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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| 510(K) Database | 510(K)s with Product Code = NFB
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