AngioDynamics Solero Microwave Tissue Ablation (MTA) System: Solero Generator PG (1) Catalog Number:12740000 UPN: H78712740000 (2) Solero Generator US PG Catalog Number: 12740000US UPN: H78712740000US0 (3) Solero Generator Service Loaner PG Catalog No: 12740000L UPN: H78712740000L0 (4) Solero Generator Service Loaner US PG Catalog Number: 12740000USL UPN: H78712740000USL0
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial Numbers: (1) QBY0002022 QBY0001996 QBY0001997 QBY0002018 QBY0002303 QBY0002031 QBY0002020 QBY0002032 QBY0002016 QBY0002208 QBY0002017 QBY0002019 QBY0001990 QBY0002000 QBY0001989 QBY0001991 QBY0001995 QBY0001992 QBY0002024 QBY0001998 QBY0001999 QBY0002023 QBY0002012 QBY0002013 QBY0002009 QBY0002015 QBY0002014 QBY0002005 QBY0002011 QBY0002045 QBY0002046 QBY0002047 QBY0002048 QBY0002049 QBY0002050 QBY0002210 QBY0002209 QBY0002057 QBY0002304 QBY0002302 QBY0002308 QBY0002309 QBY0002307 QBY0002351 QBY0002350 QBY0002353 QBY0002349 QBY0002355 QBY0002354 QBY0002357 QBY0002346 QBY0002344 QBY0002345 QBY0002358 QBY0002348 QBY0002356 QBY0002369 QBY0002371 QBY0002372 QBY0002370 QBY0002368 QBY0002364 QBY0002365 QBY0002363 QBY0002427 QBY0002359 QBY0002362 QBY0002360 QBY0002432 QBY0002430 QBY0002428 QBY0002431 QBY0002433 QBY0002434 QBY0002479 QBY0002480 QBY0002481 QBY0002510 QBY0002511 QBY0002512 QBY0002513 QBY0002514 QBY0002523 QBY0002530 QBY0002531 QBY0002532 QBY0002533 QBY0002563 QBY0002564 QBY0002565 QBY0002566 QBY0002571 QBY0002572 QBY0002573 QBY0002574 QBY0002575 QBY0002576 QBY0002622 QBY0002623 QBY0002624 QBY0002625 QBY0002626 QBY0002627 QBY0002629 QBY0002630 QBY0002631 QBY0002651 QBY0002652 QBY0002653 QBY0002655 QBY0002656 QBY0002657 QBY0002658 QBY0002659 QBY0002660 QBY0002661 QBY0002672 QBY0002673 QBY0002674 QBY0002675 QBY0002676 QBY0002677 QBY0002678 QBY0002679 QBY0002680 QBY0002694 QBY0002699 QBY0002700 QBY0002701 QBY0002702 QBY0002703 QBY0002709 QBY0002712 QBY0002713 QBY0002714 QBY0002715 QBY0002716 QBY0002717 QBY0002718 QBY0002731 QBY0002732 QBY0002733 QBY0002744 QBY0002745 QBY0002746 QBY0002743 QBY0002739 QBY0002737 QBY0002738 QBY0002734 QBY0002735 QBY0002736 QBY0002776 QBY0002777 QBY0002837 QBY0002779 QBY0002780 QBY0002782 QBY0002783 QBY0002784 QBY0002785 QBY0002786 QBY0002788 QBY0002789 QBY0002790 QBY0002791 QBY0002792 QBY0002793 QBY0002794 QBY0002796 QBY0002797 QBY0002810 QBY0002823 QBY0002824 QBY0002821 QBY0002822 QBY0002816 QBY0002817 QBY0002819 QBY0002814 QBY0002815 QBY0002812 QBY0002813 QBY0002833 QBY0002826 QBY0002832 QBY0002839 QBY0002840 QBY0002841 QBY0002842 QBY0002857 QBY0002858 QBY0002861 QBY0002911 QBY0002912 QBY0002913 QBY0002910 QBY0002925 QBY0003039 QBY0002939 QBY0003020 QBY0003038 QBY0003023 QBY0003019 QBY0002928 QBY0002929 QBY0002940 QBY0002941 QBY0003021 QBY0003022 QBY0003027 QBY0003024 QBY0003025 QBY0003161 QBY0003175 QBY0003183 QBY0003182 QBY0003209 QBY0003214 QBY0003217 QBY0003222 QBY0003223 QBY0003224 QBY0003226 QBY0003294 QBY0003295 QBY0003109 QBY0003134 QBY0003136 QBY0003145; (2): QBY0002288 QBY0002300 QBY0002297 QBY0002291 QBY0002282 QBY0002292 QBY0002283 QBY0002286 QBY0002376 QBY0002375 QBY0002379 QBY0002383 QBY0002381 QBY0002382 QBY0002385 QBY0002389 QBY0002393 QBY0002397 QBY0002471 QBY0002516 QBY0002517 QBY0002519 QBY0002520 QBY0002526 QBY0002527 QBY0002534 QBY0002542 QBY0002543 QBY0002552 QBY0002553 QBY0002545 QBY0002546 QBY0002547 QBY0002549 QBY0002554 QBY0002569 QBY0002570 QBY0002611 QBY0002612 QBY0002613 QBY0002615 QBY0002618 QBY0002619 QBY0002662 QBY0002663 QBY0002664 QBY0002668 QBY0002665 QBY0002669 QBY0002670 QBY0002671 QBY0002682 QBY0002683 QBY0002684 QBY0002687 QBY0002690 QBY0002704 QBY0002758 QBY0002759 QBY0002763 QBY0002764 QBY0002762 QBY0002765 QBY0002825 QBY0002845 QBY0002848 QBY0002846 QBY0002847 QBY0002862 QBY0002863 QBY0002889 QBY0002890 QBY0002885 QBY0002886 QBY0002887 QBY0002934 QBY0002914 QBY0002931 QBY0002932 QBY0003016 QBY0002930 QBY0002933 QBY0002956 QBY0002957 QBY0002958 QBY0002978 QBY0003017 QBY0003178 QBY0003179 QBY0003180 QBY0003181 QBY0003177 QBY0003186 QBY0003210 QBY0003211 QBY0003218 QBY0003219 QBY0003232 QBY0003303 QBY0003297 QBY0003314 QBY0003315 QBY0003064 QBY0003065 QBY0003066 QBY0003110 QBY0003111; (3) QBY0002361; (4) QBY0002306 QBY0002616
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Reason for Recall:
- Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: Solero Generator PG (1) Catalog Number:12740000 UPN: H78712740000 (2) Solero Generator US PG Catalog Number: 12740000US UPN: H78712740000US0 (3) Solero Generator Service Loaner PG Catalog No: 12740000L UPN: H78712740000L0 (4) Solero Generator Service Loaner US PG Catalog Number: 12740000USL UPN: H78712740000USL0
Product Codes/Lot Numbers:
Serial Numbers: (1) QBY0002022 QBY0001996 QBY0001997 QBY0002018 QBY0002303 QBY0002031 QBY0002020 QBY0002032 QBY0002016 QBY0002208 QBY0002017 QBY0002019 QBY0001990 QBY0002000 QBY0001989 QBY0001991 QBY0001995 QBY0001992 QBY0002024 QBY0001998 QBY0001999 QBY0002023 QBY0002012 QBY0002013 QBY0002009 QBY0002015 QBY0002014 QBY0002005 QBY0002011 QBY0002045 QBY0002046 QBY0002047 QBY0002048 QBY0002049 QBY0002050 QBY0002210 QBY0002209 QBY0002057 QBY0002304 QBY0002302 QBY0002308 QBY0002309 QBY0002307 QBY0002351 QBY0002350 QBY0002353 QBY0002349 QBY0002355 QBY0002354 QBY0002357 QBY0002346 QBY0002344 QBY0002345 QBY0002358 QBY0002348 QBY0002356 QBY0002369 QBY0002371 QBY0002372 QBY0002370 QBY0002368 QBY0002364 QBY0002365 QBY0002363 QBY0002427 QBY0002359 QBY0002362 QBY0002360 QBY0002432 QBY0002430 QBY0002428 QBY0002431 QBY0002433 QBY0002434 QBY0002479 QBY0002480 QBY0002481 QBY0002510 QBY0002511 QBY0002512 QBY0002513 QBY0002514 QBY0002523 QBY0002530 QBY0002531 QBY0002532 QBY0002533 QBY0002563 QBY0002564 QBY0002565 QBY0002566 QBY0002571 QBY0002572 QBY0002573 QBY0002574 QBY0002575 QBY0002576 QBY0002622 QBY0002623 QBY0002624 QBY0002625 QBY0002626 QBY0002627 QBY0002629 QBY0002630 QBY0002631 QBY0002651 QBY0002652 QBY0002653 QBY0002655 QBY0002656 QBY0002657 QBY0002658 QBY0002659 QBY0002660 QBY0002661 QBY0002672 QBY0002673 QBY0002674 QBY0002675 QBY0002676 QBY0002677 QBY0002678 QBY0002679 QBY0002680 QBY0002694 QBY0002699 QBY0002700 QBY0002701 QBY0002702 QBY0002703 QBY0002709 QBY0002712 QBY0002713 QBY0002714 QBY0002715 QBY0002716 QBY0002717 QBY0002718 QBY0002731 QBY0002732 QBY0002733 QBY0002744 QBY0002745 QBY0002746 QBY0002743 QBY0002739 QBY0002737 QBY0002738 QBY0002734 QBY0002735 QBY0002736 QBY0002776 QBY0002777 QBY0002837 QBY0002779 QBY0002780 QBY0002782 QBY0002783 QBY0002784 QBY0002785 QBY0002786 QBY0002788 QBY0002789 QBY0002790 QBY0002791 QBY0002792 QBY0002793 QBY0002794 QBY0002796 QBY0002797 QBY0002810 QBY0002823 QBY0002824 QBY0002821 QBY0002822 QBY0002816 QBY0002817 QBY0002819 QBY0002814 QBY0002815 QBY0002812 QBY0002813 QBY0002833 QBY0002826 QBY0002832 QBY0002839 QBY0002840 QBY0002841 QBY0002842 QBY0002857 QBY0002858 QBY0002861 QBY0002911 QBY0002912 QBY0002913 QBY0002910 QBY0002925 QBY0003039 QBY0002939 QBY0003020 QBY0003038 QBY0003023 QBY0003019 QBY0002928 QBY0002929 QBY0002940 QBY0002941 QBY0003021 QBY0003022 QBY0003027 QBY0003024 QBY0003025 QBY0003161 QBY0003175 QBY0003183 QBY0003182 QBY0003209 QBY0003214 QBY0003217 QBY0003222 QBY0003223 QBY0003224 QBY0003226 QBY0003294 QBY0003295 QBY0003109 QBY0003134 QBY0003136 QBY0003145; (2): QBY0002288 QBY0002300 QBY0002297 QBY0002291 QBY0002282 QBY0002292 QBY0002283 QBY0002286 QBY0002376 QBY0002375 QBY0002379 QBY0002383 QBY0002381 QBY0002382 QBY0002385 QBY0002389 QBY0002393 QBY0002397 QBY0002471 QBY0002516 QBY0002517 QBY0002519 QBY0002520 QBY0002526 QBY0002527 QBY0002534 QBY0002542 QBY0002543 QBY0002552 QBY0002553 QBY0002545 QBY0002546 QBY0002547 QBY0002549 QBY0002554 QBY0002569 QBY0002570 QBY0002611 QBY0002612 QBY0002613 QBY0002615 QBY0002618 QBY0002619 QBY0002662 QBY0002663 QBY0002664 QBY0002668 QBY0002665 QBY0002669 QBY0002670 QBY0002671 QBY0002682 QBY0002683 QBY0002684 QBY0002687 QBY0002690 QBY0002704 QBY0002758 QBY0002759 QBY0002763 QBY0002764 QBY0002762 QBY0002765 QBY0002825 QBY0002845 QBY0002848 QBY0002846 QBY0002847 QBY0002862 QBY0002863 QBY0002889 QBY0002890 QBY0002885 QBY0002886 QBY0002887 QBY0002934 QBY0002914 QBY0002931 QBY0002932 QBY0003016 QBY0002930 QBY0002933 QBY0002956 QBY0002957 QBY0002958 QBY0002978 QBY0003017 QBY0003178 QBY0003179 QBY0003180 QBY0003181 QBY0003177 QBY0003186 QBY0003210 QBY0003211 QBY0003218 QBY0003219 QBY0003232 QBY0003303 QBY0003297 QBY0003314 QBY0003315 QBY0003064 QBY0003065 QBY0003066 QBY0003110 QBY0003111; (3) QBY0002361; (4) QBY0002306 QBY0002616
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1700-2019
Related Recalls
Xcela PICC with PASV Valve Technology/Kit 5 F-55cm; (Maximum Flow Rate 3.5 mL/Sec)-indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, and nutrients; the sampling of blood; and for power injection of contrast media. Catalog Number: 60M701995
Angiodynamics Inc. (Navilyst Medical Inc.)
Mislabeled: The product is labeled as 5F (55cm; Maximum Flow Rate 3.5 mL/Sec) and the product is actually 4F (55cm; Maximum Flow Rate 3.5 mL/Sec).
AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer Catalogue #: VI10 - Product Usage: For the introduction of various types of pacing leads and catheters.
Angiodynamics Inc. (Navilyst Medical Inc.)
AngioDynamics, Inc. is recalling a specific batch of AngioDynamics Implantable Infusion Port kits and Valved introducers that may have potential for compromised sterility of the device. Only the specific product/lot of the kit identified below is affected by this recall action. The Product Description, Product Number, Ref./Catalog Number and Batch/Lot number is provided below. No other products are affected by this recall.
Smart Port CT-Implantable Port Catalogue #: CT96STSD-VI, CT96STSA-VI - Product Usage: indicated for any patient requiring repeated access of the vascular system, for delivery of medications, nutritional supplementation, fluids, blood, blood products, and sampling of blood and power injection of contrast media for imaging.
Angiodynamics Inc. (Navilyst Medical Inc.)
AngioDynamics, Inc. is recalling a specific batch of AngioDynamics Implantable Infusion Port kits and Valved introducers that may have potential for compromised sterility of the device. Only the specific product/lot of the kit identified below is affected by this recall action. The Product Description, Product Number, Ref./Catalog Number and Batch/Lot number is provided below. No other products are affected by this recall.