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    D/C CORE MATERIAL

    FDA 510(k)
    FDA Class 2 ·Dental

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036008147·

    UNIVERSAL BLADE IMP

    FDA Adverse Event
    Other ·CALCITEK·Product code DZE·February 7, 1997

    BRACHYSEED

    FDA 510(k)
    FDA Class 2 ·Radiology

    HEALTH-PLUS, SANITEX, RELIANCE, POWDERED LATEX EXAM GLOVES CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PR

    FDA 510(k)
    FDA Class 1 ·General Hospital

    CELSITE ACCESS PORT

    FDA Adverse Event
    Malfunction ·B. BRAUN MEDICAL SAS·Product code LJT·October 23, 2014

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·May 11, 2007

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·March 19, 2013

    TALENT THORACIC STENT GRAFT SYSTEM

    FDA Adverse Event
    Death ·MEDTRONIC CARDIOVASCULAR·Product code MIH·March 3, 2011

    DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·September 15, 2022

    DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·September 14, 2022

    Oridion CO2 sampling lines and water traps under the label: MicroStreamC02 Sampling Lines: FilterLine Set Adult/Pediatric -Part No: XS04620-01; FilterLine Set Adult/Pediatric (100 unit boxes)-Part No. 010579; FilterLine H Set Adult/Pediatric -Part No. XS04624 ; FilterLine H Set Adult/Pediatric (100 unit boxes) Part No: 010580; FilterLine H Set Infant/Neonatal-Part No. 006324; FilterLine Set Adult/Pediatric Long Part No. 007768; FilterLine H Set Adult/Pediatric Long Part No. 007737; FilterLine H Set Infant/Neonatal Long Part No. 007738 Smart CapnoLine Plus (O2 connector) Part No. 009818 Smart CapnoLine Plus (O2 connector) (Special 100 unit boxes) - Part No.; 010209; Smart CapnoLine Plus Long (O2 connector) Part No. 010340; Smart CapnoLine Plus Long (O2 connector) (Special 100 unit boxes) Part No: 010339; Smart CapnoLine Plus O2 (O2 tubing) Part No. 009822 Smart CapnoLine Plus O2 (O2 tubing) (Special 100 unit boxes) Part No. 010210; Smart CapnoLine Plus O2 Long (O2 tubing) Part No. 009826; Smart CapnoLine Plus O2 Long (O2 tubing) (Special 100 unit boxes) , Part No. 010341; Smart CapnoLine Pediatric Part No. 007266 Smart CapnoLine O2 Pediatric (O2 tubing) Part No. 07269; Smart CapnoLine O2 Pediatric Long (O2 tubing) Part No.007743; Smart CapnoLine H Plus O2 (O2 tubing) Part No. 010433; Smart CapnoLine H O2 Adult (O2 tubing) Part No. 010478; Smart CapnoLine H O2 Intermediate (O2 tubing) Part No; 010475; Smart CapnoLine H Pediatric (O2 connector) Part No. 010581; Smart CapnoLine H O2 Pediatric (O2 tubing) Part No. 010582 O2 CO2 Nasal FilterLine Adult (O2 connector) Part No. 010207; O2 CO2 Nasal FilterLine Adult (O2 tubing) Part No. 006912; O2 CO2 Nasal FilterLine Adult Long (O2 connector) Part No. 010342; O2 CO2 Nasal FilterLine Adult Long (O2 tubing) Part No. 007739; O2 CO2 Nasal FilterLine Pediatric (O2 tubing) Pat No. 006913; O2 CO2 Nasal FilterLine Long (O2 tubing) Part No 007740; NIV Line Adult Part No. 008174; NIV Line Pediatric Part No. 008175; Nasal FilterLine Infant/Neonatal Part No. XS0447; CapnoLine H Adult Part No. 008177; CapnoLine H Pediatric Part No. 008178; CapnoLine H Infant/Neonatal Part No. 008179; CapnoLine H O2 Adult (O2 tubing) Part No. 008180; CapnoLine H O2 Pediatric (O2 tubing) Part No. 008181; CapnoLine H O2 Infant/Neonatal (O2 tubing) Part No. 012111; VitaLine H Set Adult/Pediatric Part No. 010787; VitaLine H Set Infant/Neonatal Part No. 010807; FilterLine XL Part No. 006325; Smart CapnoLine Guardian Part No. 012528; Smart CapnoLine Guardian O2 Part No. 012529; Smart CapnoLine Guardian O2 Long Part No. 012530

    FDA Recall
    Terminated ·Oridion Medical·Product code CCK·February 16, 2012

    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K09/K09T (Custom Manifold Kit), REF: K09-00526L K09-00807AH K09-01467AD K09-01467AF K09-01514U K09-01734L K09-02040C K09-02683F K09-02804B K09-03844F K09-04088H K09-04088J K09-04863J K09-04946B K09-04998H K09-04998HP K09-05229JP K09-05342A K09-05375F K09-05939D K09-07759J K09-07789L K09-07789M K09-07828U K09-07828UP K09-07834C K09-07905G K09-08031D K09-08052Q K09-08065J K09-08150R K09-08423G K09-08493KP K09-08847A K09-08875B K09-09051H K09-09184B K09-09403HP K09-09481A K09-09499B K09-09814 K09-09900F K09-09902G K09-09902GP K09-09975 K09-10060F K09-10062F K09-10210A K09-10210B K09-10286G K09-10300F K09-10315B K09-10432A K09-10444J K09-10475 K09-10494C K09-10574D K09-10726 K09-10736D K09-10788A K09-10811 K09-10829B K09-10830C K09-10929 K09-10994D K09-11024DP K09-11076C K09-11107D K09-11149B K09-11196 K09-11207DP K09-11259G K09-11259GP K09-11444B K09-11482D K09-11607B K09-11646C K09-11913C K09-12030AP K09-12245A K09-12304A K09-12304B K09-12359B K09-12396FP K09-12404 K09-12556B K09-12615 K09-12698 K09-12698A K09-12699 K09-12699A K09-12699B K09-12704A K09-12867A K09-12899A K09-12939B K09-12939C K09-13082C K09-13171 K09-13228A K09-13337BP K09-13420 K09-13507CP K09-13617P K09-13659AP K09-13660 K09-13767 K09-13880 K09-13882 K09-13882A K09-13933 K09-14000 K09-14000A K09-14047 K09-14096 K09-14196 K09-14219 K09-14220 K09T-13643 To support fluid administration into the body. To support various vascular or cardiac diagnostic and interventional procedures.

    FDA Recall
    Open, Classified ·Merit Medical Systems, Inc.·Product code OEZ·June 11, 2024

    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K09/K09T (Custom Manifold Kit), REF: K09-00526L K09-00807AH K09-01467AD K09-01467AF K09-01514U K09-01734L K09-02040C K09-02683F K09-02804B K09-03844F K09-04088H K09-04088J K09-04863J K09-04946B K09-04998H K09-04998HP K09-05229JP K09-05342A K09-05375F K09-05939D K09-07759J K09-07789L K09-07789M K09-07828U K09-07828UP K09-07834C K09-07905G K09-08031D K09-08052Q K09-08065J K09-08150R K09-08423G K09-08493KP K09-08847A K09-08875B K09-09051H K09-09184B K09-09403HP K09-09481A K09-09499B K09-09814 K09-09900F K09-09902G K09-09902GP K09-09975 K09-10060F K09-10062F K09-10210A K09-10210B K09-10286G K09-10300F K09-10315B K09-10432A K09-10444J K09-10475 K09-10494C K09-10574D K09-10726 K09-10736D K09-10788A K09-10811 K09-10829B K09-10830C K09-10929 K09-10994D K09-11024DP K09-11076C K09-11107D K09-11149B K09-11196 K09-11207DP K09-11259G K09-11259GP K09-11444B K09-11482D K09-11607B K09-11646C K09-11913C K09-12030AP K09-12245A K09-12304A K09-12304B K09-12359B K09-12396FP K09-12404 K09-12556B K09-12615 K09-12698 K09-12698A K09-12699 K09-12699A K09-12699B K09-12704A K09-12867A K09-12899A K09-12939B K09-12939C K09-13082C K09-13171 K09-13228A K09-13337BP K09-13420 K09-13507CP K09-13617P K09-13659AP K09-13660 K09-13767 K09-13880 K09-13882 K09-13882A K09-13933 K09-14000 K09-14000A K09-14047 K09-14096 K09-14196 K09-14219 K09-14220 K09T-13643 To support fluid administration into the body. To support various vascular or cardiac diagnostic and interventional procedures.

    FDA Enforcement
    Class II ·Ongoing·Merit Medical Systems, Inc.·August 21, 2024

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH 0 DEGREE LINER 28MM 46MM, REF 130-28-05; b. ACUMATCH 0 DEGREE LINER 28MM 48MM, REF 130-28-06; c. ACUMATCH 0 DEGREE LINER 28MM 50/52MM, REF 130-28-07; d. ACUMATCH 0 DEGREE LINER 28MM 54/56MM, REF 130-28-08; e. ACUMATCH 0 DEGREE LINER 28MM 58/64MM, REF 130-28-09; f. ACUMATCH 15 DEGREE LINER 22MM SZ D, REF 132-22-04; g. ACUMATCH 15 DEGREE LINER 22MM SZ E, REF 132-22-05; h. ACUMATCH 15 DEGREE LINER 22MM SZ F, REF 132-22-06; i. ACUMATCH 15 DEGREE LINER 22MM SZ G, REF 132-22-07; j. ACUMATCH 15 DEGREE LINER 22MM SZ H, REF 132-22-08; k. ACUMATCH 15 DEGREE LINER 28MM SZ E, REF 132-28-05; l. ACUMATCH 15 DEGREE LINER 28MM SZ F, REF 132-28-06; m. ACUMATCH 15 DEGREE LINER 28MM SZ G, REF 132-28-07; n. ACUMATCH 15 DEGREE LINER 28MM SZ H, REF 132-28-08; o. ACUMATCH 15 DEGREE LINER 28MM SZ J, REF 132-28-09; p. ACUMATCH 15 DEGREE LINER 28MM SZ K, REF 132-28-10; q. ACUMATCH 15 DEGREE LINER 32MM SZ G, REF 132-32-07; r. ACUMATCH 15 DEGREE LINER 32MM SZ H, REF 132-32-08; s. ACUMATCH 15 DEGREE LINER 32MM SZ J, REF 132-32-09; t. ACUMATCH 15 DEGREE LINER 32MM SZ K, REF 132-32-10; u. ACUMATCH EXT COV LINER 28MM 46MM, REF 134-28-05; v. ACUMATCH EXT COV LINER 28MM 48MM, REF 134-28-06; w. ACUMATCH EXT COV LINER 28MM 50/52MM, REF 134-28-07; x. ACUMATCH EXT COV LINER 28MM 54/56MM, REF 134-28-08; y. ACUMATCH EXT COV LINER 28MM 58/64MM, REF 134-28-09; z. ACUMATCH EXT COV LINER 28MM 66/70MM, REF 134-28-10; aa. ACUMATCH LAT LINER 28MM 46MM, REF 138-28-05; bb. ACUMATCH LAT LINER 28MM 48MM, REF 138-28-06; cc. ACUMATCH LAT LINER 28MM 50/52MM, REF 138-28-07; dd. ACUMATCH LAT LINER 28MM 54/56MM, REF 138-28-08; ee. ACUMATCH LAT LINER 28MM 58/64MM, REF 138-28-09; ff. ACUMATCH 15 DEG LINER, SZ F, 28MM ID, REF CSK-1663; gg. ACUMATCH 15 DEG LINER, SZ G, 28MM ID, REF CSK-1664; hh. ACUMATCH 15 DEG LINER, SZ H, 28MM ID, REF CSK-1665

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022

    Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (Sp02) and cardiac output. Acquired data may then be communicated to all information network for display, recording, editing and analysis.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 6, 2015