BEUDAMED
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    Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) PRE OP KIT, Medline kit SKU DYKS1093B; 2) PRE OP KIT, Medline kit SKU DYKS1124C; 3) PRE OP KIT, Medline kit SKU DYKS1128C; 4) PREOP KIT, Medline kit SKU DYKS1130B; 5) PRE OP KIT, Medline kit SKU DYKS1163G; 6) PRE OP KIT SURGERY, Medline kit SKU DYKS1263G; 7) PREOP KIT, Medline kit SKU DYKS1313A; 8) PRE OP KIT, Medline kit SKU DYKS1325A; 9) ADULT PRE OP KIT, Medline kit SKU DYKS1337D; 10) PRE OP KIT ADULT, Medline kit SKU DYKS1362A; 11) PRE-OP - OUTPATIENT KIT, Medline kit SKU DYKS1378B; 12) PRE-OP INPATIENT KIT, Medline kit SKU DYKS1379B; 13) PRE OP KIT, Medline kit SKU DYKS1382A; 14) PRE OP KIT, Medline kit SKU DYKS1416F; 15) PREOP KIT, Medline kit SKU DYKS1448B; 16) PRE-OP KIT, Medline kit SKU DYKS1458F; 17) PRE OP KIT, Medline kit SKU DYKS1467B; 18) PRE OP KIT, Medline kit SKU DYKS1468; 19) PRE-OP, Medline kit SKU DYKS1482A; 20) ADULT PRE OP, Medline kit SKU DYKS1487I; 21) PRE OP ENDO, Medline kit SKU DYKS1489F; 22) PREOP KIT, Medline kit SKU DYKS1507B; 23) PRE OP KIT, Medline kit SKU DYKS1518A; 24) PRE OP KIT, Medline kit SKU DYKS1544F; 25) PREOP, Medline kit SKU DYKS1551B; 26) PREOP, Medline kit SKU DYKS1552B; 27) PREOP, Medline kit SKU DYKS1580; 28) PRE OP KIT, Medline kit SKU DYKS2024A; 29) PRE OP KIT, Medline kit SKU DYKS2056A; 30) PRE-OP KIT, Medline kit SKU DYKS2074; 31) PRE-OP KIT, Medline kit SKU DYKS2074A; 32) PREOP KIT, Medline kit SKU DYKS2076; 33) PRE OP KIT 1, Medline kit SKU DYKS2083; 34) PRE OP KIT, Medline kit SKU DYKS2103.

    FDA Recall
    Open, Classified ·Product code OJU·November 26, 2025

    BARD Mesh Pre-shaped (1.8" x 4.0"/4.5cm x 10cm) Product code: 0112700 Intended use: Bard Pre-shaped mesh is a pre-shaped mesh constructed of knitted polypropylene monofilaments. It is indicated for the repair of inguinal hernia defects

    FDA Recall
    Terminated ·Davol, Inc., Sub. C. R. Bard, Inc.·Product code FTL·October 15, 2010

    ARCHITECT B12 Reagent, list 06C09-22 (4 x 100 tests), 06C09-27 (1 x 100 tests); an in vitro diagnostic kit consisting of microparticles, conjugate, assay diluent, pre-treatment 1, pre-treatment 2, and pre-treatment 3; Abbott Laboratories, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories MPG·Product code LIG·March 8, 2006

    Preview Strep A, Streptococcal A rapid test kits, Part Numbers: a) PRE-STA-25, b) PRE-STA-A-10

    FDA Recall
    Open, Classified ·Wondfo USA Co Ltd·Product code GTY·April 22, 2024

    cobas p 612 pre-analytical system; Pre-analytical sample handling that includes de-capping, Aliquotting and sorting of samples for analysis.

    FDA Recall
    Terminated ·Roche Diagnostics Corporation·Product code JQP·December 27, 2016

    cobas p 512 pre-analytical system Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code JQP·February 23, 2016

    Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) DELUXE PRE OP KIT, Medline SKU DYKS2034A; 2) DELUXE PRE OP KIT, Medline SKU DYKS2006B.

    FDA Recall
    Open, Classified ·Product code OFF·November 26, 2025

    Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) DRAWER 2 IV SUPPLIES, Medline kit SKU ACC010271B; 2) DRAWER 2 IV FLUIDS & TUBING, Medline kit SKU ACC010416B; 3) OXYGENATION & TUBING TRAY, Medline kit SKU ACC010525C; 4) TOP DRAWER #6, Medline kit SKU ACC010688; 5) RRMC CODE CART DRAWER 3, Medline kit SKU ACC010770; 6) SURGERY BAG, Medline kit SKU DYKM1279C; 7) ADMISSION KIT, Medline kit SKU DYKS1179; 8) PRE OP KIT, Medline kit SKU DYKS1192C; 9) MEDLINE PEDIATRIC PATIENT PACK, Medline kit SKU DYKS1199B; 10) MEDLINE ADULT PATIENT PACKAGE, Medline kit SKU DYKS1200B; 11) GERMANTOWN PRE OP KIT, Medline kit SKU DYKS1248; 12) GERMANTOWN PRE OP BLOCK KIT, Medline kit SKU DYKS1249; 13) PRE OP KIT, Medline kit SKU DYKS1274A; 14) CATH LAB PRE OP START KIT, Medline kit SKU DYKS1324; 15) PRE OP KIT, Medline kit SKU DYKS1376; 16) PTC KIT, Medline kit SKU DYNDH1161A; 17) DR BROWN BODY, Medline kit SKU DYNJ910487.

    FDA Recall
    Open, Classified ·Product code LRO·November 26, 2025

    Medline Kits, trays, and packs labeled as follows: a) C L PREP, REF DYNJ69664; b) DMEK PREP PACK, REF DYNJ81659A; c) PRE OP KIT 1, REF DYKS1377; d) PRE OP KIT 1, REF DYKS1377A

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OJU·November 15, 2023

    Pre Isotonic Personal Lubricant labeled PRE' Patient Lubricant. Product is used to lubricate vulvar and vaginal tissues to facilitate entry of diagnostic or therapeutic devices. Pre' Lubricant is acceptable for use to facilitate insertion of diagnostic or therapeutic devices during fertility interventions such as: embryo transfer, transvaginal collection of oocytes, intrauterine insemination and post coital testing. In addition, product may be used as a personal lubricant to supplement the body's own natural lubricating fluids.

    FDA Recall
    Terminated ·INGfertility, LLC·Product code NUC·September 22, 2008

    Cordis Neurovascular Pre-Shaped PROWLER Infusion Catheters.

    FDA Recall
    Terminated ·Cordis Neurovascular, Inc.·Product code KRA·August 11, 2006

    cobas p 501 Post-Analytical Unit calculator/data processing module, for clinical use Product Usage: The MODULAR PRE-ANALYTICS system is a fully automated system for sample pre-processing, including centrifuging, aliquoting, and barcode labeling, prior to analysis by MODULAR SYSTEMS analyzers.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code JQP·July 15, 2016

    Gingihue 15 Degree Pre-Angled Post Dental implants

    FDA Recall
    Terminated ·Biomet 3i, LLC·Product code NHA·November 25, 2015

    Preformance 15 degrees pre-angled post Dental implants

    FDA Recall
    Terminated ·Biomet 3i, LLC·Product code NHA·November 25, 2015

    Cordis Neurovascular Pre-Shaped Prowler Select Infusion Catheters.

    FDA Recall
    Terminated ·Cordis Neurovascular, Inc.·Product code KRA·August 11, 2006

    MEDLINE PRE-OP CHG BATHING KIT Reorder #: P164756

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code LRO·September 9, 2022

    Certain Gingihue 15 degree Pre- Angled Post Dental implants

    FDA Recall
    Terminated ·Biomet 3i, LLC·Product code NHA·November 25, 2015

    Certain Preformance 15 degrees Pre-Angled Post Dental implants

    FDA Recall
    Terminated ·Biomet 3i, LLC·Product code NHA·November 25, 2015

    Sierra Pre-Filled, Heparin Lock Flush Solution USP, 10 units/ml, Catalog #3003-06, NDC #64054-3003-06, 3mL Fill in a 6mL Syringe, 120/Case, For Single Use only, Sterile Solution Pathway, For IV Flush, Sierra Pre-Filled Inc., 455 W. Depot St. Angier, NC 27501

    FDA Recall
    Terminated ·AM2 PAT INC·Product code FOZ·December 11, 2007

    Sierra Pre-Filled, Heparin Lock Flush Solution USP, 10 units/ml, Catalog #3005-02, NDC #64054-3005-02, 5mL Fill in a 12mL Syringe, 120/Case, For Single Use only, Sterile Solution Pathway, For IV Flush, Sierra Pre-Filled Inc., 455 W. Depot St. Angier, NC 27501

    FDA Recall
    Terminated ·AM2 PAT INC·Product code FOZ·December 11, 2007