DrugMar 11, 2020
Fusion IV Pharmaceuticals, Inc. dba Axia Methionine/Inositol/Choline Injection recall — FDA D-0965-2020
Lack of Assurance of Sterility
Class IIFDA: TerminatedFusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
March 2020 recalls — page 12
These records include useful source details for the selected month.
DrugMar 11, 2020
Fusion IV Pharmaceuticals, Inc. dba Axia Glycine Injection,GLYCINE USP 50MG/ML INJECTABLE recall — FDA D-0955-2020
Lack of Assurance of Sterility
Class IIFDA: TerminatedFusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
DrugMar 11, 2020
Fusion IV Pharmaceuticals, Inc. dba Axia Alprostadil (prostaglandin E1) 80 MCG/ML recall — FDA D-0936-2020
Lack of Assurance of Sterility
Class IIFDA: TerminatedFusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
DrugMar 11, 2020
Fusion IV Pharmaceuticals, Inc. dba Axia Glutathione Injection,GLUTATHIONE 200MG/ML recall — FDA D-0953-2020
Lack of Assurance of Sterility
Class IIFDA: TerminatedFusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
DrugMar 11, 2020
Fusion IV Pharmaceuticals, Inc. dba Axia AscorbiX (Buffered C) Injection, Ascorbix (50ML) recall — FDA D-0940-2020
Lack of Assurance of Sterility
Class IIFDA: TerminatedFusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
DrugMar 11, 2020
Fusion IV Pharmaceuticals, Inc. dba Axia Selenium Injection, SELENIUM 200MCG/ML INJECTABLE recall — FDA D-0981-2020
Lack of Assurance of Sterility
Class IIFDA: TerminatedFusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
DrugMar 11, 2020
Fusion IV Pharmaceuticals, Inc. dba Axia Methylprednisolone Acetate Injectable Suspension recall — FDA D-0971-2020
Lack of Assurance of Sterility
Class IIFDA: TerminatedFusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
DrugMar 11, 2020
Fusion IV Pharmaceuticals, Inc. dba Axia BETAMETHASONE ACETATE/BETAMETHASONE (PF) Injectable recall — FDA D-0943-2020
Lack of Assurance of Sterility
Class IIFDA: TerminatedFusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
DrugMar 11, 2020
Fusion IV Pharmaceuticals, Inc. dba Axia Alprostadil/Papaverine Hydrochloride/Phentolamine recall — FDA D-0937-2020
Lack of Assurance of Sterility
Class IIFDA: TerminatedFusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
DrugMar 11, 2020
Fusion IV Pharmaceuticals, Inc. dba Axia Polyoxyl Lauryl Ether (Polidocanol) Injection recall — FDA D-0960-2020
Lack of Assurance of Sterility
Class IIFDA: TerminatedFusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
Medical DeviceMar 4, 2020
MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil recall — FDA Z-1393-2020
The devices may be missing the implant coil.
Class IIFDA: TerminatedMicrovention, Inc.
Medical DeviceMar 4, 2020
Biomet 3i CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 6MM(H) Reference recall — FDA Z-1368-2020
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Class IIFDA: TerminatedBiomet 3i, LLC
Medical DeviceMar 4, 2020
Medline HOI LUMBAR REF DYNJ902823G Lot 20AKA895 Expiration 2021-05-31 1 each GTIN recall — FDA Z-1357-2020
The sterile pack inside the Complete Delivery System (CDS) did not go through a complete sterilization cycle, therefore the sterility of these components cannot be guaranteed.
Class IIFDA: TerminatedMedline Industries Inc.
Medical DeviceMar 4, 2020
Biomet 3i CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 3MM(H) Reference recall — FDA Z-1378-2020
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Class IIFDA: TerminatedBiomet 3i, LLC
Medical DeviceMar 4, 2020
BIOMERIEUX - Grenoble NUCLISENS Lysis Buffer, IVD, REF 200292, 48X2 ML LYS Manufacturer recall — FDA Z-1365-2020
Following a customer complaint about colored eluates, leading to invalid results bioMerieux has confirmed an issue with NUCLISENS Lysis Buffer, ref. 200292, lot 19040201. The issue is…
Class IIFDA: TerminatedBIOMERIEUX - Grenoble
Medical DeviceMar 4, 2020
Biomet 3i CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 4MM(H) Reference recall — FDA Z-1370-2020
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Class IIFDA: TerminatedBiomet 3i, LLC
Medical DeviceMar 4, 2020
MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil recall — FDA Z-1396-2020
The devices may be missing the implant coil.
Class IIFDA: TerminatedMicrovention, Inc.
Medical DeviceMar 4, 2020
Biomet 3i CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H) Reference recall — FDA Z-1386-2020
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Class IIFDA: TerminatedBiomet 3i, LLC
Medical DeviceMar 4, 2020
MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization Coil recall — FDA Z-1405-2020
The devices may be missing the implant coil.
Class IIFDA: TerminatedMicrovention, Inc.
Medical DeviceMar 4, 2020
MicroVention Terumo Microplex 18, Platinum Embolization Coil, Cosmos 18, Sterile, Rx, REF recall — FDA Z-1399-2020
The devices may be missing the implant coil.
Class IIFDA: TerminatedMicrovention, Inc.
Medical DeviceMar 4, 2020
Siemens Healthcare Diagnostics ADVIA Chemistry Lipase, Ref recall — FDA Z-1363-2020
Firm has received customer complaints regarding failed calibrations and increased imprecision of quality control and patient samples when using this product.
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
Medical DeviceMar 4, 2020
Biomet 3i CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 7.5MM(P) X 4MM(H) Reference recall — FDA Z-1388-2020
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Class IIFDA: TerminatedBiomet 3i, LLC
Medical DeviceMar 4, 2020
MicroVention Terumo HydroFrame 10, HydroCoil Embolic System, Endovascular Embolization Coil recall — FDA Z-1402-2020
The devices may be missing the implant coil.
Class IIFDA: TerminatedMicrovention, Inc.
Medical DeviceMar 4, 2020
MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil recall — FDA Z-1398-2020
The devices may be missing the implant coil.
Class IIFDA: TerminatedMicrovention, Inc.
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.