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U.S. Department of Health and Human Services

Class 2 Device Recall CAREEVAC 3

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  Class 2 Device Recall CAREEVAC 3 see related information
Date Initiated by Firm August 14, 2018
Date Posted September 07, 2018
Recall Status1 Terminated 3 on December 15, 2020
Recall Number Z-2995-2018
Recall Event ID 80785
510(K)Number K062610  
Product Classification Pump, portable, aspiration (manual or powered) - Product Code BTA
Product Portable Suction Pump, (a) Style 758010, Model CARE-E-VAC 3, Ohio Medical LLC; (b) Style 758000, Model CARE-E-VAC 3, Ohio Medical LLC

The care-e-(R)3 is a portable medical aspirator used to suction fluids or foreign bodies from a patient. The primary intended use is to aspirate saliva, mucous, vomitus or other aspirant from the mouth or airway to allow adequate respiration or ventilation of the patient.
Code Information (a) style 758010 Serial Numbers: CDS5000 CDS5001 CDS5002 CDS5003 CDS5004 CDS5005 CDS5006 CDS5007 CDS5008 CDS5009 CDS5010 CDS5011 CDS5012 CDS5013 CDS5014 CDS5015 CDS5016 CDS5017 CDS5018 CDS5019 CDS5020 CDS5021 CDS5022 CDS5023 CDS5024 CDS5025 CDS5026 CDS5027 CDS5028 CDS5029 CDS5030 CDS5031 CDS5032 CDS5033 CDS5034 CDS5035 CDS5036 CDS5037 CDS5038 CDS5039 CDS5040 CDS5041 CDS5042 CDS5043 CDS5044 CEV3X0076 CEV3X0077 CEV3X0078 CEV3X0079 CEV3X0080 CEV3X0081 CEV3X0082 CEV3X0083 CEV3X0084 CEV3X0085 CEV3X0086 CEV3X0087 CEV3X0088 CEV3X0089 CEV3X0090 CEV3X0091 CEV3X0092 CEV3X0093 CEV3X0094 CEV3X0095 CEV3X0096 CEV3X0097 CEV3X0098 CEV3X0099 CEV3X0100 CEV3X0101 CEV3X0102 CEV3X0103 CEV3X0104 CEV3X0105 CEV3X0106 CEV3X0107 CEV3X0108 CEV3X0109 CEV3X0110 CEV3X0111 CEV3X0112 CEV3X0113 CEV3X0114 CEV3X0115 CEV3X0116 CEV3X0117 CEV3X0118 CEV3X0119 CEV3X0120 CEV3X0121 CEV3X0122 CEV3X0123 CEV3X0124 CEV3X0125 CEV3X0176 CEV3X0177 CEV3X0178 CEV3X0179 CEV3X0180 CEV3X0181 CEV3X0182 CEV3X0183 CEV3X0184 CEV3X0185 CEV3X0186 CEV3X0187 CEV3X0188 CEV3X0189 CEV3X0190 CEV3X0191 CEV3X0192 CEV3X0193 CEV3X0194 CEV3X0195 CEV3X0196 CEV3X0197 CEV3X0198 CEV3X0199 CEV3X0200 CEV3X0201 CEV3X0202 CEV3X0203 CEV3X0204 CEV3X0205 CEV3X0206 CEV3X0207 CEV3X0208 CEV3X0209 CEV3X0210 CEV3X0211 CEV3X0212 CEV3X0213 CEV3X0214 CEV3X0215 CEV3X0216 CEV3X0217 CEV3X0218 CEV3X0219 CEV3X0220 CEV3X0221 CEV3X0222 CEV3X0223 CEV3X0224 CEV3X0225 CEV3X0462 CEV3X0463 CEV3X0464 CEV3X0465 CEV3X0466 CEV3X0467 CEV3X0468 CEV3X0469 CEV3X0470 CEV3X0471 CEV3X0472 CEV3X0473 CEV3X0474 CEV3X0475 CEV3X0476 CEV3X0477 CEV3X0478 CEV3X0479   (b) style 758000 Serial Numbers: CDS0081 CDS0082 CDS0083 CDS0084 CDS0085 CDS0086 CDS0087 CDS0088 CDS0089 CDS0090 CDS0091 CDS0092 CDS0093 CDS0094 CDS0095 CDS0096 CDS0097 CDS0098 CDS0099 CDS0100 CDS0101 CDS0102 CDS0103 CDS0104 CDS0105 CDS0106 CDS0107 CDS0108 CDS0109 CDS0110 CDS0111 CDS0112 CDS0113 CDS0114 CDS0115 CDS0116 CDS0117 CDS0118 CDS0119 CDS0120 CDS0121 CDS0122 CDS0123 CDS0124 CDS0125 CDS0126 CDS0127 CDS0128 CDS0129 CDS0130 CDS0131 CDS0132 CDS0133 CDS0134 CDS0135 CDS0136 CDS0137 CDS0138 CDS0139 CDS0140 CDS0141 CDS0142 CDS0143 CDS0144 CDS0145 CDS0146 CDS0147 CDS0148 CDS0149 CDS0150 CDS0151 CDS0152 CDS0153 CDS0154 CDS0155 CDS0156 CDS0157 CDS0158 CDS0159 CDS0160 CDS0161 CDS0162 CDS0163 CDS0164 CDS0165 CDS0166 CDS0167 CDS0168 CDS0169 CDS0170 CDS0171 CDS0172 CDS0173 CDS0174 CDS0175 CDS0176 CDS0177 CDS0178 CDS0179 CDS0180 CDS0181 CDS0182 CDS0183 CDS0184 CDS0185 CDS0186 CDS0187 CDS0188 CDS0189 CDS0190 CDS0191 CDS0192 CDS0193 CDS0194 CDS0195 CDS0196 CDS0197 CDS0198 CDS0199 CDS0200 CDS0201 CDS0202 CDS0203 CDS0204 CDS0205 CDS0206 CDS0207 CDS0208 CDS0209 CDS0210 CDS0211 CDS0212 CDS0213 CDS0214 CDS0215 CDS0216 CDS0217 CDS0218 CDS0219 CDS0220 CDS0221 CDS0222 CDS0223 CDS0224 CDS0225 CDS0226 CDS0227 CDS0228 CDS0229 CDS0230 CDS0231 CDS0232 CDS0233 CDS0234 CDS0235 CDS0236 CDS0237 CDS0238 CDS0239 CDS0240 CDS0241 CDS0242 CDS0243 CDS0244 CDS0245 CDS0246 CDS0247 CDS0248 CDS0249 CDS0250 CDS0251 CDS0252 CDS0253 CDS0254 CDS0255 CDS0256 CDS0257 CDS0258 CDS0259 CDS0260 CDS0261 CDS0262 CDS0263 CDS0264 CDS0265 CDS0266 CDS0267 CDS0268 CDS0269 CDS0270 CDS0271 CDS0272 CDS0273 CDS0274 CDS0275 CDS0276 CDS0277 CDS0278 CDS0279 CDS0280 CDS0281 CDS0282 CDS0283 CDS0284 CDS0285 CDS0286 CDS0287 CDS0288 CDS0289 CDS0290 CDS0291 CDS0292 CDS0293 CDS0294 CDS0295 CDS0296 CDS0297 CDS0298 CDS0299 CDS0300 CDS0301 CDS0302 CDS0303 CDS0304 CDS0305 CDS0306 CDS0307 CDS0308 CDS0309 CDS0310 CDS0311 CDS0312 CDS0313 CDS0314 CDS0315 CDS0316 CDS0317 CDS0318 CDS0319 CDS0320 CDS0321 CDS0322 CDS0323 CDS0324 CDS0325 CDS0326 CDS0327 CDS0328 CDS0329 CDS0330 CDS0331 CDS0332 CDS0333 CDS0334 CDS0335 CDS0336 CDS0337 CDS0338 CDS0339 CDS0340 CDS0341 CDS0342 CDS0343 CDS0344 CDS0345 CDS0346 CDS0347 CDS0348 CDS0349 CDS0350 CDS0351 CDS0352 CDS0353 CDS0354 CDS0355 CDS0356 CDS0357 CDS0358 CDS0359 CDS0360 CDS0361 CDS0362 CDS0363 CDS0364 CDS0365 CDS0366 CDS0367 CDS0368 CDS0369 CDS0370 CDS0371 CDS0372 CDS0373 CDS0374 CDS0375 CDS0376 CDS0377 CDS0378 CDS0379 CDS0380 CDS0381 CDS0382 CDS0383 CDS0384 CDS0385 CDS0386 CDS0387 CDS0388 CDS0389 CDS0390 CDS0391 CDS0392 CDS0393 CDS0394 CDS0395 CDS0396 CDS0397 CDS0398 CDS0399 CDS0400 CDS0401 CDS0402 CDS0403 CDS0404 CDS0405 CDS0406 CDS0407 CDS0408 CDS0409 CDS0410 CDS0411 CDS0412 CDS0413 CDS0414 CDS0415 CDS0416 CDS0417 CDS0418 CDS0419 CDS0420 CDS0421 CDS0422 CDS0423 CDS0424 CDS0425 CDS0426 CDS0427 CDS0428 CDS0429 CDS0430 CDS0431 CDS0432 CDS0433 CDS0434 CDS0435 CDS0436 CDS0437 CDS0438 CDS0439 CDS0440 CDS0441 CDS0442 CDS0443 CDS0444 CDS0445 CDS0446 CDS0447 CDS0448 CDS0449 CDS0450 CDS0451 CDS0452 CDS0453 CDS0454 CDS0455 CDS0456 CDS0457 CDS0458 CDS0459 CDS0460 CDS0461 CDS0462 CDS0463 CDS0464 CDS0465 CDS0466 CDS0467 CDS0468 CDS0469 CDS0470 CDS0471 CDS0472 CDS0473 CDS0474 CDS0475 CDS0476 CDS0477 CDS0478 CDS0479 CDS0480 CDS0481 CDS0482 CDS0483 CDS0484 CDS0485 CDS0486 CDS0487 CDS0488 CDS0489 CDS0490 CDS0491 CDS0492 CDS0493 CDS0494 CDS0495 CDS0496 CDS0497 CDS0498 CDS0499 CDS0500 CDS0501 CDS0502 CDS0503 CDS0504 CDS0505 CDS0506 CDS0507 CDS0508 CDS0509 CDS0510 CDS0511 CDS0512 CDS0513 CDS0514 CDS0515 CDS0516 CDS0517 CDS0518 CDS0519 CDS0520 CDS0521 CDS0522 CDS0523 CDS0524 CDS0525 CDS0526 CDS0527 CDS0528 CDS0529 CDS0530 CDS0531 CDS0532 CDS0533 CDS0534 CDS0535 CDS0536 CDS0537 CDS0538 CDS0539 CDS0540 CDS0541 CDS0542 CDS0543 CDS0544 CDS0545 CDS0546 CDS0547 CDS0548 CDS0549 CDS0550 CDS0551 CDS0552 CDS0553 CDS0554 CDS0555 CDS0556 CDS0557 CDS0558 CDS0559 CDS0560 CDS0561 CDS0562 CDS0563 CDS0564 CDS0565 CDS0566 CDS0567 CDS0568 CDS0569 CDS0570 CDS0571 CDS0572 CDS0573 CDS0574 CDS0575 CDS0576 CDS0577 CDS0578 CDS0579 CDS0580 CDS0581 CDS0582 CDS0583 CDS0584 CDS0585 CDS0586 CDS0587 CDS0588 CDS0589 CDS0590 CDS0591 CDS0592 CDS0593 CDS0594 CDS0595 CDS0596 CDS0597 CDS0598 CDS0599 CDS0600 CDS0601 CDS0602 CDS0603 CDS0604 CDS0605 CDS0606 CDS0607 CDS0608 CDS0609 CDS0610 CDS0611 CDS0612 CDS0613 CDS0614 CDS0615 CDS0616 CDS0617 CDS0618 CDS0619 CDS0620 CDS0621 CDS0622 CDS0623 CDS0624 CDS0625 CDS0626 CDS0627 CDS0628 CDS0629 CDS0630 CDS0631 CDS0632 CDS0633 CDS0634 CDS0635 CDS0636 CDS0637 CDS0638 CDS0639 CDS0640 CDS0641 CDS0642 CDS0643 CDS0644 CDS0645 CDS0646 CDS0647 CDS0648 CDS0649 CDS0650 CDS0651 CDS0652 CDS0653 CDS0654 CDS0655 CDS0656 CDS0657 CDS0658 CDS0659 CDS0660 CDS0661 CDS0662 CDS0663 CDS0664 CDS0665 CDS0666 CDS0667 CDS0668 CDS0669 CDS0670 CDS0671 CDS0672 CDS0673 CDS0674 CDS0675 CDS0676 CDS0677 CDS0678 CDS0679 CDS0680 CDS0681 CDS0682 CDS0683 CDS0684 CDS0685 CDS0686 CDS0687 CDS0688 CDS0689 CDS0690 CDS0691 CDS0692 CDS0693 CDS0694 CDS0695 CDS0696 CDS0697 CDS0698 CDS0699 CDS0700 CDS0701 CDS0702 CDS0703 CDS0704 CDS0705 CDS0706 CDS0707 CDS0708 CDS0709 CDS0710 CDS0711 CDS0712 CDS0713 CDS0714 CDS0715 CDS0716 CDS0717 CDS0718 CDS0719 CDS0720 CDS0721 CDS0722 CDS0723 CDS0724 CDS0725 CDS0726 CDS0727 CDS0728 CDS0729 CDS0730 CDS0731 CDS0732 CDS0733 CDS0734 CDS0735 CDS0736 CDS0737 CDS0738 CDS0739 CDS0740 CDS0741 CDS0742 CDS0743 CDS0744 CDS0745 CDS0746 CDS0747 CDS0748 CDS0749 CDS0750 CDS0751 CDS0752 CDS0753 CDS0754 CDS0755 CDS0756 CDS0757 CDS0758 CDS0759 CDS0760 CDS0761 CDS0762 CDS0763 CDS0764 CDS0765 CDS0766 CDS0767 CDS0768 CDS0769 CDS0770 CDS0771 CDS0772 CDS0773 CDS0774 CDS0775 CDS0776 CDS0777 CDS0778 CDS0779 CDS0780 CDS0781 CDS0782 CDS0783 CDS0784 CDS0785 CDS0786 CDS0787 CDS0788 CDS0789 CDS0790 CDS0791 CDS0792 CDS0793 CDS0794 CDS0795 CDS0796 CDS0797 CDS0798 CDS0799 CDS0800 CDS0801 CDS0802 CDS0803 CDS0804 CDS0805 CDS0806 CDS0807 CDS0808 CDS0809 CDS0810 CDS0811 CDS0812 CDS0813 CDS0814 CDS0815 CDS0816 CDS0817 CDS0818 CDS0819 CDS0820 CDS0821 CDS0822 CDS0823 CDS0824 CDS0825 CDS0826 CDS0827 CDS0828 CDS0829 CDS0830 CDS0831 CDS0832 CDS0833 CDS0834 CDS0835 CDS0836 CDS0837 CDS0838 CDS0839 CDS0840 CDS0841 CDS0842 CDS0843 CDS0844 CDS0845 CDS0846 CDS0847 CDS0848 CDS0849 CDS0850 CDS0851 CDS0852 CDS0853 CDS0854 CDS0855 CDS0856 CDS0857 CDS0858 CDS0859 CDS0860 CDS0861 CDS0862 CDS0863 CDS0864 CDS0865 CDS0866 CDS0867 CDS0868 CDS0869 CDS0870 CDS0871 CDS0872 CDS0873 CDS0874 CDS0875 CDS0876 CDS0877 CDS0878 CDS0879 CDS0880 CDS0881 CDS0882 CDS0883 CDS0884 CDS0885 CDS0886 CDS0887 CDS0888 CDS0889 CDS0890 CDS0891 CDS0892 CDS0893 CDS0894 CDS0895 CDS0896 CDS0897 CDS0898 CDS0899 CDS0900 CDS0901 CDS0902 CDS0903 CDS0904 CDS0905 CDS0906 CDS0907 CDS0908 CDS0909 CDS0910 CDS0911 CDS0912 CDS0913 CDS0914 CDS0915 CDS0916 CDS0917 CDS0918 CDS0919 CDS0920 CDS0921 CDS0922 CDS0923 CDS0924 CDS0925 CDS0926 CDS0927 CDS0928 CDS0929 CDS0930 CDS0931 CDS0932 CDS0933 CDS0934 CDS0935 CDS0936 CDS0937 CDS0938 CDS0939 CDS0940 CDS0941 CDS0942 CDS0943 CDS0944 CDS0945 CDS0946 CDS0947 CDS0948 CDS0949 CDS0950 CDS0951 CDS0952 CDS0953 CDS0954 CDS0955 CDS0956 CDS0957 CDS0958 CDS0959 CDS0960 CDS0961 CDS0962 CDS0963 CDT0001 CDT0002 CDT0003 CDT0004 CDT0005 CDT0006 CDT0007 CDT0008 CDT0009 CDT0010 CDT0011 CDT0012 CDT0013 CDT0014 CDT0015 CDT0016 CDT0017 CDT0018 CDT0019 CDT0020 CDT0021 CDT0022 CDT0023 CDT0024 CDT0025 CDT0026 CDT0027 CDT0028 CDT0029 CDT0030 CDT0031 CDT0032 CDT0033 CDT0034 CDT0035 CDT0036 CDT0037 CDT0038 CDT0039 CDT0040 CDT0041 CDT0042 CDT0043 CDT0044 CDT0045 CDT0046 CDT0047 CDT0048 CDT0049 CDT0050 CDT0051 CDT0052 CDT0053 CDT0054 CDT0055 CDT0056 CDT0057 CDT0058 CDT0059 CDT0060 CDT0061 CDT0062 CDT0063 CDT0064 CDT0065 CDT0066 CDT0067 CDT0068 CDT0069 CDT0070 CDT0071 CDT0072 CDT0073 CDT0074 CDT0075 CDT0076 CDT0077 CDT0078 CDT0079 CDT0080 CDT0081 CDT0082 CDT0083 CDT0084 CDT0085 CDT0086 CDT0087 CDT0088 CEV3X0001 CEV3X0002 CEV3X0003 CEV3X0004 CEV3X0005 CEV3X0006 CEV3X0007 CEV3X0008 CEV3X0009 CEV3X0010 CEV3X0011 CEV3X0012 CEV3X0013 CEV3X0014 CEV3X0015 CEV3X0016 CEV3X0017 CEV3X0018 CEV3X0019 CEV3X0020 CEV3X0021 CEV3X0022 CEV3X0023 CEV3X0024 CEV3X0025 CEV3X0026 CEV3X0027 CEV3X0028 CEV3X0029 CEV3X0030 CEV3X0031 CEV3X0032 CEV3X0033 CEV3X0034 CEV3X0035 CEV3X0036 CEV3X0037 CEV3X0038 CEV3X0039 CEV3X0040 CEV3X0041 CEV3X0042 CEV3X0043 CEV3X0044 CEV3X0045 CEV3X0046 CEV3X0047 CEV3X0048 CEV3X0049 CEV3X0050 CEV3X0051 CEV3X0052 CEV3X0053 CEV3X0054 CEV3X0055 CEV3X0056 CEV3X0057 CEV3X0058 CEV3X0059 CEV3X0060 CEV3X0061 CEV3X0062 CEV3X0063 CEV3X0064 CEV3X0065 CEV3X0066 CEV3X0067 CEV3X0068 CEV3X0069 CEV3X0070 CEV3X0071 CEV3X0072 CEV3X0073 CEV3X0074 CEV3X0075 CEV3X0126 CEV3X0127 CEV3X0128 CEV3X0129 CEV3X0130 CEV3X0131 CEV3X0132 CEV3X0133 CEV3X0134 CEV3X0135 CEV3X0136 CEV3X0137 CEV3X0138 CEV3X0139 CEV3X0140 CEV3X0141 CEV3X0142 CEV3X0143 CEV3X0144 CEV3X0145 CEV3X0146 CEV3X0147 CEV3X0148 CEV3X0149 CEV3X0150 CEV3X0151 CEV3X0152 CEV3X0153 CEV3X0154 CEV3X0155 CEV3X0156 CEV3X0157 CEV3X0158 CEV3X0159 CEV3X0160 CEV3X0161 CEV3X0162 CEV3X0163 CEV3X0164 CEV3X0165 CEV3X0166 CEV3X0167 CEV3X0168 CEV3X0169 CEV3X0170 CEV3X0171 CEV3X0172 CEV3X0173 CEV3X0174 CEV3X0175 CEV3X0226 CEV3X0227 CEV3X0228 CEV3X0229 CEV3X0230 CEV3X0231 CEV3X0232 CEV3X0233 CEV3X0234 CEV3X0235 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Recalling Firm/
Manufacturer		 Ohio Medical Corporation
1111 Lakeside Dr
Gurnee IL 60031-2489
For Additional Information Contact Jessica Barrile
847-855-6318
Manufacturer Reason
for Recall		 The care-e-vac(R)3 Battery/AC Powered Portable Aspirator battery terminal may come in contact with the pump causing an electric short leading to damage to wiring and resulting in loss of function or an inoperable unit under battery power.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The firm, Ohio Medical, sent an "URGENT  MEDICAL DEVICE CORRECTION NOTIFICATION" letter dated 8/7/2018 to its customers on 8/14/2018. The letter described the product, problem and actions to be taken. The customers were instructed to take the affected care-e-vac¿3 units out of service and follow the instructions, site: https://www.ohiomedical.com/4897450, provided with this notification to change the orientation of the battery; If, upon opening the device, you identify damage to wiring, please contact Ohio Medical Customer Service at 866.549.6446 or email to customer.service@ohiomedical.com for additional instructions to replace the wiring harness; and complete the attached Customer Acknowledgement Form and return it to our Quality Assurance Department at 847/855-6304 (fax), email to: CEV3_FCA@ohiomedical.com, or mail in the envelope provided to: Ohio Medical LLC, ATTN: Quality Assurance Department, 1111 Lakeside Drive, Gurnee, IL 60031. Please direct questions to Sr. Director, QA/RA at 847-855-6326 or email: barbara-ann.conway-myers@ohiomedical.com.
Quantity in Commerce 1443 units
Distribution US Nationwide Distribution and internationally to countries: Canada, Saudi Arabia, and United Arab Emirates.
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = BTA and Original Applicant = OHIO MEDICAL CORPORATION
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