FDAFDA · Food and drugs·Recall number Z-2767-2019
Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage: Distends uterus with fluid during diagnostic and operative hysteroscopies.
Published October 9, 2019 · Recall initiated: August 14, 2019
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
The deficit displayed by the pump can differ from the real deficit, leading potentially to patient risk.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- WOM World of Medicine AG
- Distributor
- US Nationwide Distribution
- Lot
- UDI: 04056702006556 Serial Numbers: 1802CE0558 1803CE0226 1803CE0835 1804CE0075 1804CE0487 1804CE0912 1805CE0592 1802CE0559 1803CE0227 1803CE0869 1804CE0153 1804CE0488 1804CE0913 1805CE0593 1802CE0560 1803CE0228 1803CE0870 1804CE0154 1804CE0489 1804CE0914 1805CE0594 1802CE0561 1803CE0229 1803CE0871 1804CE0155 1804CE0490 1804CE0915 1805CE0595 1802CE0562 1803CE0230 1803CE0872 1804CE0156 1804CE0491 1804CE0916 1805CE0596 1802CE0563 1803CE0231 1803CE0873 1804CE0157 1804CE0492 1804CE0917 1805CE0597 1802CE0564 1803CE0232 1803CE0874 1804CE0158 1804CE0493 1804CE0918 1805CE0598 1802CE0565 1803CE0233 1803CE0875 1804CE0159 1804CE0494 1804CE0919 1805CE0599 1802CE0566 1803CE0234 1803CE0876 1804CE0160 1804CE0495 1804CE0920 1805CE0600 1802CE0567 1803CE0235 1803CE0877 1804CE0212 1804CE0648 1805CE0031 1805CE0640 1803CE0024 1806CE0520 1803CE0878 1804CE0213 1804CE0649 1805CE0032 1805CE0641 1803CE0025 1803CE0498 1803CE0926 1804CE0214 1804CE0650 1805CE0033 1805CE0642 1803CE0026 1803CE0499 1803CE0927 1804CE0215 1804CE0651 1805CE0034 1805CE0643 1803CE0027 1803CE0500 1803CE0928 1804CE0216 1804CE0652 1805CE0035 1805CE0644 1803CE0028 1803CE0501 1803CE0929 1804CE0217 1804CE0653 1805CE0036 1805CE0645 1803CE0029 1803CE0502 1803CE0930 1804CE0218 1804CE0654 1805CE0037 1805CE0646 1803CE0030 1803CE0503 1803CE0931 1804CE0219 1804CE0655 1805CE0038 1805CE0647 1803CE0031 1803CE0504 1803CE0932 1804CE0220 1804CE0656 1805CE0039 1805CE0648 1803CE0032 1803CE0505 1803CE0933 1804CE0221 1804CE0657 1805CE0040 1805CE0649 1803CE0033 1803CE0506 1803CE0934 1804CE0260 1804CE0737 1805CE0099 1805CE0742 1803CE0064 1803CE0507 1803CE0935 1804CE0261 1804CE0738 1805CE0100 1805CE0743 1803CE0065 1803CE0562 1803CE1118 1804CE0262 1804CE0739 1805CE0101 1805CE0744 1803CE0066 1803CE0563 1803CE1119 1804CE0263 1804CE0740 1805CE0102 1805CE0745 1803CE0067 1803CE0564 1803CE1120 1804CE0264 1804CE0741 1805CE0103 1805CE0746 1803CE0068 1803CE0565 1803CE1121 1804CE0265 1804CE0742 1805CE0104 1805CE0747 1803CE0069 1803CE0566 1803CE1122 1804CE0266 1804CE0743 1805CE0105 1805CE0748 1803CE0070 1803CE0567 1803CE1123 1804CE0267 1804CE0744 1805CE0106 1805CE0749 1803CE0071 1803CE0568 1803CE1124 1804CE0268 1804CE0745 1805CE0107 1805CE0750 1803CE0072 1803CE0569 1803CE1125 1804CE0269 1804CE0746 1805CE0108 1805CE0751 1803CE0073 1803CE0570 1803CE1126 1804CE0355 1804CE0791 1805CE0336 1806CE0214 1803CE0111 1803CE0571 1803CE1127 1804CE0356 1804CE0792 1805CE0337 1806CE0215 1803CE0112 1803CE0628 1803CE1168 1804CE0357 1804CE0793 1805CE0338 1806CE0216 1803CE0113 1803CE0629 1803CE1169 1804CE0358 1804CE0794 1805CE0339 1806CE0217 1803CE0114 1803CE0630 1803CE1170 1804CE0359 1804CE0795 1805CE0340 1806CE0218 1803CE0115 1803CE0631 1803CE1171 1804CE0360 1804CE0796 1805CE0341 1806CE0219 1803CE0116 1803CE0632 1803CE1172 1804CE0361 1804CE0797 1805CE0342 1806CE0220 1803CE0117 1803CE0633 1803CE1173 1804CE0362 1804CE0798 1805CE0343 1806CE0221 1803CE0118 1803CE0634 1803CE1174 1804CE0363 1804CE0799 1805CE0344 1806CE0222 1803CE0119 1803CE0635 1803CE1175 1804CE0364 1804CE0800 1805CE0345 1806CE0223 1803CE0120 1803CE0636 1803CE1176 1804CE0436 1804CE0841 1805CE0412 1806CE0308 1803CE0166 1803CE0637 1803CE1177 1804CE0437 1804CE0842 1805CE0413 1806CE0309 1803CE0167 1803CE0826 1804CE0066 1804CE0438 1804CE0843 1805CE0414 1806CE0310 1803CE0168 1803CE0827 1804CE0067 1804CE0439 1804CE0844 1805CE0415 1806CE0311 1803CE0169 1803CE0828 1804CE0068 1804CE0440 1804CE0845 1805CE0416 1806CE0312 1803CE0170 1803CE0829 1804CE0069 1804CE0441 1804CE0846 1805CE0417 1806CE0313 1803CE0171 1803CE0830 1804CE0070 1804CE0442 1804CE0847 1805CE0418 1806CE0314 1803CE0172 1803CE0831 1804CE0071 1804CE0443 1804CE0848 1805CE0419 1806CE0315 1803CE0173
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Germany
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