FDAFDA · Food and drugs·Recall number Z-1661-2013
VenaFlow Elite 30B-B and 30BI-B Product Usage: The VenaFlow Elite System is a compression pump used for the prevention of Deep Vein Thrombosis.
Published July 10, 2013 · Recall initiated: May 28, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
DJO, LLC has recently identified a product safety issue with the battery assembly for the VenaFlow 30B-B and 30 BI-B products. There is a potential for battery leakage which could result in thermal meltdown (fire).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- DJO, LLC
- Distributor
- Worldwide Distribution - USA Nationwide and countries of: Australia, Belgium, China, Guatemala CentroAmeria, France, Hong Kong, India,Italy, Korea, Lebanon, Malaysia, Morocco, Pakistan, Paraguay, The Netherlands, Romania, Singapore, Spain, Sweden, Thailand, Turkey, United Arab Emirates, United Kingdom and Venezula.
- Lot
- Model Numbers: 30B-B and 30BI-B. Serial Numbers: E00026 E00029 E00030 E00031 E00036 E00039 E00045 E00050 E00051 E00052 E00053 E00056 E00057 E00058 E00060 E00143 E00147 E00151 E00156 E00163 E00169 E00175 E00178 E00184 E00191 E00200 E00201 E00203 E00205 E00206 E00211 E00211 E00222 E00227 E00234 E00236 E00238 E00239 E00240 E00241 E00242 E00243 E00245 E00246 E00247 E00248 E00250 E00252 E00258 E00260 E00261 E00262 E00264 E00267 E00269 E00271 E00272 E00273 E00274 E00276 E00281 E00283 E00289 E00296 E00298 E00301 E00303 E00305 E00306 E00308 E00313 E00314 E00315 E00317 E00321 E00322 E00326 E00329 E00330 E00332 E00335 E00336 E00337 E00339 E00340 E00342 E00344 E00347 E00348 E00351 E00352 E00357 E00358 E00363 E00368 E00370 E00371 E00373 E00375 E00376 E00377 E00379 E00380 E00381 E00384 E00385 E00388 E00390 E00391 E00392 E00393 E00394 E00395 E00396 E00397 E00398 E00399 E00400 E00401 E00402 E00403 E00404 E00406 E00407 E00408 E00409 E00410 E00411 E00412 E00413 E00414 E00415 E00416 E00417 E00418 E00419 E00420 E00422 E00426 E00429 E00430 E00432 E00433 E00434 E00436 E00437 E00439 E00492 E00503 E00516 E00529 E00533 E00540 E00541 E00543 E00546 E00548 E00559 E00563 E00570 E00576 E00577 E00580 E00582 E00583 E00584 E00585 E00589 E00590 E00591 E00594 E00595 E00596 E00598 E00599 E00600 E00602 E00604 E00605 E00606 E00607 E00608 E00609 E00610 E00611 E00612 E00613 E00614 E00615 E00616 E00617 E00618 E00619 E00620 E00621 E00622 E00623 E00628 E00629 E00630 E00631 E00632 E00634 E00635 E00636 E00637 E00638 E00639 E00642 E00643 E00644 E00645 E00646 E00647 E00649 E00651 E00652 E00656 E00657 E00658 E00659 E00660 E00661 E00662 E00663 E00664 E00665 E00666 E00669 E00670 E00672 E00673 E00675 E00676 E00677 E00679 E00680 E00682 E00683 E00686 E00687 E00688 E00689 E00692 E00693 E00696 E00698 E00699 E00700 E00701 E00703 E00704 E00705 E00706 E00707 E00708 E00710 E00712 E00714 E00715 E00716 E00718 E00719 E00720 E00723 E00724 E00725 E00727 E00728 E00730 E00733 E00734 E00735 E00736 E00737 E00739 E00740 E00741 E00743 E00744 E00745 E00746 E00747 E00748 E00749 E00750 E00752 E00759 E00760 E00761 E00762 E00763 E00764 E00765 E00766 E00767 E00768 E00769 E00770 E00771 E00772 E00773 E00774 E00775 E00778 E00779 E00786 E00787 E00789 E00791 E00795 E00796 E00797 E00798 E00800 E00806 E00809 E00811 E00812 E00813 E00815 E00822 E00839 E01016 E01018 E01019 E01020 E01021 E01022 E01023 E01024 E01025 E01027 E01028 E01029 E01030 E01032 E01033 E01035 E01036 E01037 E01038 E01041 E01042 E01043 E01044 E01045 E01046 E01047 E01048 E01051 E01053 E01054 E01055 E01057 E01058 E01059 E01060 E01061 E01062 E01063 E01064 E01065 E01066 E01067 E01068 E01071 E01072 E01074 E01076 E01079 E01080 E01081 E01082 E01083 E01084 E01085 E01086 E01087 E01088 E01089 E01090 E01092 E01093 E01094 E01095 E01097 E01098 E01099 E01101 E01102 E01103 E01104 E01105 E01166 E01167 E01168 E01169 E01170 E01171 E01172 E01173 E01174 E01175 E01176 E01177 E01179 E01180 E01183 E01186 E01188 E01189 E01190 E01191 E01192 E01193 E01194 E01195 E01196 E01198 E01200 E01201 E01204 E01205 E01206 E01207 E01208 E01209 E01211 E01212 E01213 E01217 E01219 E01221 E01224 E01226 E01228 E01229 E01230 E01231 E01232 E01234 E01235 E01238 E01239 E01240 E01242 E01245 E01247 E01248 E01249 E01250 E01251
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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