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    IMPLANT,1-PC,ANG,3.0X10MM, REF ZOP30A10; IMPLANT, 1-PC, ANG, 3.0X11.5MM, REF ZOP30A11; IMPLANT, 1 -PC,ANG,3.0X13MM, REF ZOP30A13; IMPLANT 1-PC STR 3.0X10, REF ZOP30S10; IMPLANT, 1-PC,STR,3.0X11.5MM, REF ZOP30S11; IMPLANT,1 -PC,STR,3.0X13MM, REF ZOP30S13

    FDA Enforcement
    Class II ·Terminated·Zimmer Dental Inc·October 4, 2017

    IMPLANT,1-PC,ANG,3.0X10MM, REF ZOP30A10; IMPLANT, 1-PC, ANG, 3.0X11.5MM, REF ZOP30A11; IMPLANT, 1 -PC,ANG,3.0X13MM, REF ZOP30A13; IMPLANT 1-PC STR 3.0X10, REF ZOP30S10; IMPLANT, 1-PC,STR,3.0X11.5MM, REF ZOP30S11; IMPLANT,1 -PC,STR,3.0X13MM, REF ZOP30S13

    FDA Recall
    Terminated ·Zimmer Dental Inc·Product code DZE·July 10, 2017

    BD Bioscience CD45 APC-H7 Analyte Specific Reagent, manufactured by BD Biosciences, San Jose, CA. CD45 recognizes members of the T200 family of human leucocyte antigens with molecular mass of 180 to 220 kilodaltons (kDa).

    FDA Recall
    Terminated ·BD Biosciences, Systems & Reagents·Product code MVU·November 23, 2009

    Anti-Lambda APC-H7, Catalog Number 656157. Product Usage: Intended for in vitro flow cytometric immunophenotyping of hematologic disorders.

    FDA Recall
    Terminated ·BD Biosciences, Systems & Reagents·Product code MVU·December 19, 2014

    GRIPPER Needles sold as part of PORT-A-CATH II SINGLE LUMEN SYSTEM. Labeled as the following item descriptions: 1. TRAY, PAC, VEN, TI, PU, 1.9MM, UL, 6FR/INTRO 1/EA; 2. TRAY, PAC, VEN LP, TI, PU, 1.9MM, UL, 6 FR/INTRO 1/EA; 3. TRAY, PAC II, VEN, 2.8MM, CS, 9FR/INTRO 1/EA; 4. TRAY, PAC II, VEN, TI, PU, 1.9MM, UL, 6FR/INTRO 1/EA; 5. TRAY, PAC II, VEN, PU, 2.6MM, UL, 8.5FR/INTRO 1/EA; 6. TRAY, PAC II, VEN, PU, 2.6MM, PRE-AY, 8.5FR/INTRO 1/EA; 7. TRAY, PAC II, VEN LP, PU, 2.6MM, UL, 8.5FR/INTRO, VALVED 1/EA; 8. TRAY, PAC II, VEN LP, PU, 1.9MM, UL, 6FR/INTRO, VALVED 1/EA; 9. TRAY, PAC II, VEN LP, PU, 2.6MM, UL, 8.5FR/INTRO 1/EA; 10. TRAY, PAC II, VEN LP, PU, 2.6MM, PRE-AY, 8.5 FR/INTRO 1/EA; 11. TRAY, PAC II, VEN LP, PU, 1.9MM, UL, 6FR/INTRO 1/EA; 12. TRAY, PROPORT, PLASTIC, 2PC, STD, SGL LMN, 1.0, PU 1/EA; 13. TRAY, PROPORT, PLASTIC, 2PC, STD, SGL LMN, 1.6, PU 1/EA; 14. TRAY, PROPORT, PLASTIC, 2PC, LP, SGL LMN, 1.6, PU 1/EA; 15. TRAY, PROPORT, PLASTIC, 2PC, LP, SGL LMN, 1.0, PU 1/EA; 16. TRAY, PROPORT, PLASTIC, 2PC, LP, SGL LMN, 1.0, SIL 1/EA; 17. TRAY, POWER PAC, VEN, TI, PU, 2.6MM, UL, 8.5 FR/INTRO 1/EA; 18. TRAY, POWER PAC, VEN, TI, PU, 1.9MM, UL, 6 FR/INTRO 1/EA; 19. TRAY, POWER PAC, VEN LP, TI, PU, 1.9MM, UL, 6 FR/INTRO 1/EA; 20. TRAY, POWER PAC II, VEN, TI, PU, 1.9MM, UL, 6 FR/INTRO 1/EA; 21. TRAY, POWER PAC II, VEN, PU, 2.6MM, UL 8.5 FR/INTRO 1/EA; 22. TRAY, POWER PAC II, VEN, PU, 2.6MM, PRE-AY, 8.5 FR/INTRO 1/EA; 23. TRAY, POWER PAC II, VEN LP, PU, 2.6MM, UL 8.5 FR/INTRO 1/EA; 24. TRAY, POWER PAC II, VEN, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED 1/EA; 25. TRAY, POWER PAC II, VEN LP, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED 1/EA; 26. TRAY, POWER PAC II, VEN, PU, 1.9MM, UL, 6 FR/INTRO, VALVED 1/EA; 27. TRAY, POWER PAC II, VEN, LP, PU, 1.9MM, UL, 6 FR/INTRO, VALVED 1/EA; 28. TRAY, POWER PAC II, VEN LP, PU, 1.9MM, UL, 6 FR/INTRO 1/EA; 29. TRAY, POWER PAC II, VEN LP, PU, 1.9MM, PRE-AY, 6 FR/INTRO 1/EA; 30. TRAY, POWER PAC, PASPORT T2, PU, 1.9MM, UL, 6 FR/INTRO 1/EA; 31. TRAY, PAC II, DL, LP, PU, 2.2MM, WING-LOCK, 7FR/INTRO 1/EA; 32. TRAY, POWER PAC II, DL, LP, PU, 2.2MM, WING-LOCK, 7FR, INTRO 1/EA; 33. TRAY, POWERPAC II, DL, LP, PU, 3.2MM, WING-LOCK, 10 FR/INTRO 1/EA; 34. TRAY, POWER PAC II, DL, LP, PU, 3.2MM, WING-LOCK, 10 FR/INTRO, VALVED 1/EA;

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 30, 2019

    Immulite 2500 Automated Immunoassay Analyzer, Human chorionic gonadotrpin (HCG) test system.

    FDA Recall
    Terminated ·DPC Cirrus·Product code DHA·October 29, 2004

    Immulite 2000. Immunoassay system. Software version 2.6 was to be uploaded on systems running 2.5b software.

    FDA Recall
    Terminated ·DPC Cirrus·Product code JJE·June 13, 2003

    IMMULITE 2000. An Automated, Quantitative Immunoassay Analyzer for In Vitro Diagnostic Use. Manufactured by DPC Cirrus Inc., Flanders, NJ 07836

    FDA Recall
    Terminated ·DPC Cirrus·Product code JJE·April 22, 2005

    BD" Mouse IgG2a Isotype Control APC X39 ASR

    FDA Recall
    Terminated ·Becton, Dickinson and Company, BD Biosciences·Product code MVU·July 22, 2021

    Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder Number: PMILK40, Product Sterile in Unopened/Undamaged pouch, Cotton Tip - X-Ray Detectable, 1 Pc/Pouch, 10 Pouches/Box, 20 boxes/case. Product Usage: The product is used for pushing tissue from the incision or wound during medical procedures. Per the IFU, the indications for use are for gynecological laparoscopy, laparoscopic cholecystectomy, and other laparoscopic procedures.

    FDA Enforcement
    Class II ·Terminated·Progressive Medical Inc·November 7, 2012

    BD" Mouse IgG2a Isotype Control APC X39 ASR

    FDA Enforcement
    Class II ·Terminated·Becton, Dickinson and Company, BD Biosciences·September 1, 2021

    Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder Number: PMILK40, Product Sterile in Unopened/Undamaged pouch, Cotton Tip - X-Ray Detectable, 1 Pc/Pouch, 10 Pouches/Box, 20 boxes/case. Exclusively Distributed in the U.S. Market by: Progressive Medical, Inc., St. Louis, MO, Made in China. The product is used for pushing tissue from the incision or wound during medical procedures. Per the IFU, the indications for use are for gynecological laparoscopy, laparoscopic cholecystectomy, and other laparoscopic procedures.

    FDA Enforcement
    Class II ·Terminated·Progressive Medical Inc·November 21, 2012

    Mani Trocar Kit, Model MTK23S and Model MTK25S There are 3 kits contained in one box, and sterile 1 kit consists of 3 pcs. trocar with the valved cannula and 1 pc. infusion cannula.

    FDA Enforcement
    Class II ·Terminated·Mani, Inc. - Kiyohara Facility·May 3, 2023

    Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228. (Azurion 3 M12, Azurion 3 M15, Azurion 5 M12, Azurion 5 M20, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20)

    FDA Recall
    Terminated ·Philips North America Llc·Product code JAA·September 24, 2021

    Cournand Modified 2-PC 19G, 5.4cm or (Guidewire Introducer Needle) 20 units per case The Stryker Guidewire Introducer Needles are designed for the percutaneous puncture of the anterior/posterior wall of a blood vessel. This provides an entry for a guidewire, vessel dilator, sheath, and catheter introduction.

    FDA Enforcement
    Class II ·Terminated·Stryker Instruments Div. of Stryker Corporation·December 23, 2015

    GRIPPER Needles sold as part of PORT-A-CATH II SINGLE LUMEN SYSTEM. Labeled as the following item descriptions: 1. TRAY, PAC, VEN, TI, PU, 1.9MM, UL, 6FR/INTRO 1/EA; 2. TRAY, PAC, VEN LP, TI, PU, 1.9MM, UL, 6 FR/INTRO 1/EA; 3. TRAY, PAC II, VEN, 2.8MM, CS, 9FR/INTRO 1/EA; 4. TRAY, PAC II, VEN, TI, PU, 1.9MM, UL, 6FR/INTRO 1/EA; 5. TRAY, PAC II, VEN, PU, 2.6MM, UL, 8.5FR/INTRO 1/EA; 6. TRAY, PAC II, VEN, PU, 2.6MM, PRE-AY, 8.5FR/INTRO 1/EA; 7. TRAY, PAC II, VEN LP, PU, 2.6MM, UL, 8.5FR/INTRO, VALVED 1/EA; 8. TRAY, PAC II, VEN LP, PU, 1.9MM, UL, 6FR/INTRO, VALVED 1/EA; 9. TRAY, PAC II, VEN LP, PU, 2.6MM, UL, 8.5FR/INTRO 1/EA; 10. TRAY, PAC II, VEN LP, PU, 2.6MM, PRE-AY, 8.5 FR/INTRO 1/EA; 11. TRAY, PAC II, VEN LP, PU, 1.9MM, UL, 6FR/INTRO 1/EA; 12. TRAY, PROPORT, PLASTIC, 2PC, STD, SGL LMN, 1.0, PU 1/EA; 13. TRAY, PROPORT, PLASTIC, 2PC, STD, SGL LMN, 1.6, PU 1/EA; 14. TRAY, PROPORT, PLASTIC, 2PC, LP, SGL LMN, 1.6, PU 1/EA; 15. TRAY, PROPORT, PLASTIC, 2PC, LP, SGL LMN, 1.0, PU 1/EA; 16. TRAY, PROPORT, PLASTIC, 2PC, LP, SGL LMN, 1.0, SIL 1/EA; 17. TRAY, POWER PAC, VEN, TI, PU, 2.6MM, UL, 8.5 FR/INTRO 1/EA; 18. TRAY, POWER PAC, VEN, TI, PU, 1.9MM, UL, 6 FR/INTRO 1/EA; 19. TRAY, POWER PAC, VEN LP, TI, PU, 1.9MM, UL, 6 FR/INTRO 1/EA; 20. TRAY, POWER PAC II, VEN, TI, PU, 1.9MM, UL, 6 FR/INTRO 1/EA; 21. TRAY, POWER PAC II, VEN, PU, 2.6MM, UL 8.5 FR/INTRO 1/EA; 22. TRAY, POWER PAC II, VEN, PU, 2.6MM, PRE-AY, 8.5 FR/INTRO 1/EA; 23. TRAY, POWER PAC II, VEN LP, PU, 2.6MM, UL 8.5 FR/INTRO 1/EA; 24. TRAY, POWER PAC II, VEN, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED 1/EA; 25. TRAY, POWER PAC II, VEN LP, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED 1/EA; 26. TRAY, POWER PAC II, VEN, PU, 1.9MM, UL, 6 FR/INTRO, VALVED 1/EA; 27. TRAY, POWER PAC II, VEN, LP, PU, 1.9MM, UL, 6 FR/INTRO, VALVED 1/EA; 28. TRAY, POWER PAC II, VEN LP, PU, 1.9MM, UL, 6 FR/INTRO 1/EA; 29. TRAY, POWER PAC II, VEN LP, PU, 1.9MM, PRE-AY, 6 FR/INTRO 1/EA; 30. TRAY, POWER PAC, PASPORT T2, PU, 1.9MM, UL, 6 FR/INTRO 1/EA; 31. TRAY, PAC II, DL, LP, PU, 2.2MM, WING-LOCK, 7FR/INTRO 1/EA; 32. TRAY, POWER PAC II, DL, LP, PU, 2.2MM, WING-LOCK, 7FR, INTRO 1/EA; 33. TRAY, POWERPAC II, DL, LP, PU, 3.2MM, WING-LOCK, 10 FR/INTRO 1/EA; 34. TRAY, POWER PAC II, DL, LP, PU, 3.2MM, WING-LOCK, 10 FR/INTRO, VALVED 1/EA;

    FDA Recall
    Terminated ·Smiths Medical ASD Inc.·Product code LJT·July 8, 2019

    1 pc Full Wrap Back Relief Apron, Product Number B52 Front & Back Apron, Part Numbers SEB52*F, UEB52*M Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user.

    FDA Enforcement
    Class II ·Terminated·Burlington Medical, LLC·August 7, 2019

    BD CD64 APC-R700; Analyte Specific Reagent; Model 657701; Lot No. 4344945, 5037611 and 5063945. Hematology - used as analyte specific reagent - contamination leads to possibility of unexpected staining pattern.

    FDA Recall
    Terminated ·Becton, Dickinson and Company, BD Biosciences·Product code MVU·October 30, 2015

    Anti-Lambda APC-H7, Catalog Number 656157. Product Usage: Intended for in vitro flow cytometric immunophenotyping of hematologic disorders.

    FDA Enforcement
    Class II ·Terminated·BD Biosciences, Systems & Reagents·January 28, 2015

    BioTek Gen5CL Microplate Data Collection and Analysis Software. Intended for clinical lab use with ELx800 and ELx808 microplate readers, offers preprogrammed clinical diagnostic assays within a PC-based application.

    FDA Recall
    Terminated ·BioTek Instruments, Inc. Highland Park/Box·Product code JJQ·March 12, 2009