BEUDAMED
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    REF 0930 Adult Elongated CO2/O2 Mask, 7' Tubing w/ Threaded Nut, Sivel GSE, 10' GSL X .038" ID X .107" OD, Reflective Luer Connectors, Rx Only, CE0482, (01)00709078005718 - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.

    FDA Enforcement
    Class II ·Terminated·Westmed, Inc.·January 6, 2021

    REF 0930 Adult Elongated CO2/O2 Mask, 7' Tubing w/ Threaded Nut, Sivel GSE, 10' GSL X .038" ID X .107" OD, Reflective Luer Connectors, Rx Only, CE0482, (01)00709078005718 - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.

    FDA Recall
    Terminated ·Westmed, Inc.·Product code KGB·November 11, 2020

    1 Liter Latex-Free Breathing Bags; Reservoir Bag; Vendor Part Number: 720059B, Medline Item Number: 40056; Available in various Anesthesia Circuit Kits and Complete Delivery System kits including: 1) Item Number CDS980230I, NICU-OR CDS; 2) Item Number DYNJ22691, Basin Supply Pack; 3) Item Number DYNJ24724, Spine-Crani Anesthesia Kit; 4) Item Number DYNJAAHY11, Hyperinflation System-UHS-1L; 5) Item Number DYNJAP0010, Anesthesia Circuit Ped-LF; 6) Item Number DYNJAP0011A, Pediatric Circuit-LF; 7) Item Number DYNJAP0012, Pediatric Anesthesia 40 In. CI; 8) Item Number DYNJAP0100, Pedi Breathing Circuit-LF; 9) Item Number DYNJAP0101, Anesthesia Circuit-Ped; 10) Item Number DYNJAP4012, Anesthesia Circuit Ped; 11) Item Number DYNJAP4013, Anesthesia Circuit; 12) Item Number DYNJAP4702A, Anesth Circuit Ped GS Line; 13) Item Number DYNJAP4707, Anesth Circuit 40in Ped-LF; 14) Item Number DYNJAP4722, Anes Cir 40 Ped GSEPW HYBABYH; 15) Item Number DYNJAP4729A, Circ Ped Anes Super-LF; 16) Item Number DYNJAP4730A, Circuit Pediatric Anesthesia; 17) Item Number DYNJAP4732, Anesth Circ Ped 40in 2B/V; 18) Item Number DYNJAP4740, Anesth Circ 40in Ped; 19) Item Number DYNJAP6101, Anesthesia Circuit; 20) Item Number DYNJAP6105, Anesth Circuit 60in Ped; 21) Item Number DYNJAP6106, Anes Circ Ped 60in BI GSE-LF; 22) Item Number DYNJAP6107, Anesth Circ Ped 60in ANG HME; 23) Item Number DYNJAP6108, Anesth Circuit 60in Ped; 24) Item Number DYNJAP6109, Anesth Circ Ped 60in B/V 1L-LF; 25) Item Number DYNJAP6111, Anes Cir Ped 60 GSEPW PALL FIL; 26) Item Number DYNJAP6112, Anesthesia-Peds Circuit; 27) Item Number DYNJAP6113, Circuit Pedi 60in; 28) Item Number DYNJAP6114, Anesth Circ 60in Ped; 29) Item Number DYNJAP6116, Anesth Circ 60in Ped; 30) Item Number DYNJAP6120A, Pediatric Circuit 40in LF; 31) Item Number DYNJAP6124, Anesth Circ Pedi 60in 1L GSL; 32) Item Number DYNJAP6127, Anes Circ Pedi 60in-LF; 33) Item Number DYNJAP6130, Anesth Circ Ped 60in 1L-LF; 34) Item Number DYNJAP6132A, Circuit Pediatric Anesthesia; 35) Item Number DYNJAP6133, Anesth Circuit Peds 60in-LF; 36) Item Number DYNJAP6136, Circuit Peds Anesthesia; 37) Item Number DYNJAP6137, Circuit Pediatric Anesthesia; 38) Item Number DYNJAP7217A, Anesth Circuit 72in Exp Ped BI; 39) Item Number DYNJAP7225A, Circuit Pediatric Anesthesia; 40) Item Number DYNJAP7227, Anes. 90in Exp Pedi -LF; 41) Item Number DYNJAP7233, Anes. Circuit 90in Exp Pedi-LF; 42) Item Number DYNJAP7234A, Anesthesia 72in Pediatric Exp; 43) Item Number DYNJAP7235A, Anesth Circ 72in Ped; 44) Item Number DYNJAP7236A, Anesthesia Pedi 72in; 45) Item Number DYNJAP7237, Circuit Pedi 90in EXP; 46) Item Number DYNJAP7241A, Circuit Pediatric Anesthesia; 47) Item Number DYNJAP7243B, Circ Anesth Ped 2 B/V LFree; 48) Item Number DYNJAP7246C, Circuit Pediatric Anesthesia; 49) Item Number DYNJAP7247, Anes Circ Peds 90in Exp; 50) Item Number DYNJAP7248, Anesth Circ Ped 72in Exp; 51) Item Number DYNJAP7261, Circuit Pediatric Anesthesia; 52) Item Number DYNJAP7262, Circuit Pediatric Anesthesia; 53) Item Number DYNJAP7263, Pediatric Anesthesia Circuits; 54) Item Number DYNJAP9005, Anesthesia Circuit; 55) Item Number DYNJAP9721A, Anesth Circuit Pedi HMEF LF; 56) Item Number DYNJAP9725, Pedi Expand Circuit; 57) Item Number DYNJAP9726, Anesth Circ Ped 90in; 58) Item Number DYNJAP9729, Anesth Circ 90in Exp Ped; 59) Item Number DYNJAP9730A, Circuit Pediatric 60in CORR-LF; 60) Item Number DYNJAP9732A, Circuit Pediatric Anesthesia; 61) Item Number DYNJAP9735, Peds Circuit; 62) Item Number DYNJAP9739, Circuit Pediatric Anesthesia; 63) Item Number DYNJAP9740, Circuit Pediatric Anesthesia; 64) Item Number DYNJAP9743, Circuit Pediatric Anesthesia; 65) Item Number DYNJAPF6003, Anesth Circ 60in Ped Unilimb; 66) Item Number DYNJAPF6005A, Anesth Circ 60in Uni Peds; 67) Item Number DYNJAPF6006, Anes Circ Peds 60in Uni; 68) Item Number DYNJAPF6009, Peds Anesthesia Circuit-LF; 69) Item Number DYNJAPF6011, Circuit Pediatric Anesthesia; 70) Item Number DYNJAPF601

    FDA Recall
    Terminated ·Medline Industries Inc·Product code BTC·December 7, 2007

    Dental Explorer Single End #7, Mfr. Part Code/Product Code 100-7409. Distributed under the Henry Schein label. Classification Name: 21CFR 872.4565; 510(k) exempt, Class I device, Device Listing # B057701. The product is labeled in part, HENRY SCHEIN 100-7409 Explorer - Single End #7 SE. +H65810074090C. Made in China. For professional use only. Instruments must be cleaned and sterilized prior to use. Distributed by: HENRY SCHEIN, INC. 135 Duryea Road, Melville, NY 11747 USA. --- This product is a dental explorer made of stainless steel packaged individually within a sleeve and containing a cardboard insert (labeling).

    FDA Recall
    Terminated ·Hu-Friedy Mfg Co, Inc.·Product code EKB·January 7, 2005

    Bard Recovery Cone Removal System, Catalog Numbers: RC-15. The device is intended for use for percutaneously remove the recovery filter or facilitate the retrieval of foreign objects from the peripheral vascular system.

    FDA Recall
    Terminated ·Bard Peripheral Vascular Inc·Product code GAE·May 9, 2008

    BD Bard-Parker Special Surgeon''s Peridontia Blade, Sterile, Single Use

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code GES·June 30, 2005

    "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-2740***" Ophthalmic surgery

    FDA Recall
    Terminated ·Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc. Rd·Product code GES·August 15, 2012

    Intermediate carton label reads in part as: "Bard-Parker***Stainless Steel Surgical Blades***#12B***QTY 150 (3 x 50)***REF 371712***LOT 0088464." Intended for tissue separation and other procedures that require a sharp surgical blade to puncture or cut.

    FDA Recall
    Terminated ·Aspen Surgical Puerto Rico Corp. Rd 183 Km 20.3 Las·Product code GES·June 27, 2016

    "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-3240***" Ophthalmic surgery

    FDA Recall
    Terminated ·Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc. Rd·Product code GES·August 15, 2012

    "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-2840***" Ophthalmic surgery

    FDA Recall
    Terminated ·Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc. Rd·Product code GES·August 15, 2012

    - ConMed Linvatec Spectrum II Suture Hook Crescent, Medium (Teal) 4.0 x 20.0mm. REF C6386 Lot 122592. - Arthrex SutureLasso SD, 25 Degree Tight Curve Left, Wire Loop, (Green) 1.8mm. REF AR-4068-25TL Lot 122518 and Lot 123190. -- Arthrex SutureLasso SD, 25 Degree Tight Curve Right, w/Nitinol Wire Loop, (Lt. Green) 1.8mm. REF AR-4068-25TR Lot 122518 and Lot 123190. - Arthrex SutureLasso SD, 90 Degrees (Black) 1.8mm. REF AR-4068-90 Lot 122504. - Arthrex SutureLasso, 45 Degree, Perforating Needle Cannula, w/Suture Loop, (Lt. Grey). REF AR-4065S Lot 122590. -SutureLasso, w/Wire Loop, 90 Degree, (Blue) REF AR-4065-90W Lot 123263. Manual surgical instrument for general use

    FDA Recall
    Terminated ·Surgical Instrument Service And Savings, Inc.·Product code GAE·May 3, 2013

    BD #11 Bard Parker Scalpel. A general use surgical blade, frequently used for ''stab incisions''. A non sterile, disposable, stainless steel blade. Reorder Number 371631.

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code GES·April 19, 2005

    Miltex Stainless Steel Disposable Scalpel #22, Part Number 4-422. Each box contains 10 individually packaged scalpels.

    FDA Recall
    Terminated ·Miltex, Inc.·Product code GES·April 9, 2007

    Stryker Trio Mobile Surgery Platform; Model 1033.

    FDA Recall
    Terminated ·Stryker Medical Div. of Stryker Corporation·Product code FSE·May 15, 2006

    Stainless Steel Surgical Blades Part no 4-312B. The product is supplied sterile individually packaged in boxes containing 100 blades.

    FDA Recall
    Terminated ·Miltex, Inc.·Product code GES·November 17, 2008

    "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-3040***" Ophthalmic surgery

    FDA Recall
    Terminated ·Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc. Rd·Product code GES·August 15, 2012

    Bard Recovery Cone Removal System, Catalog Numbers: FBRC. The device is intended for use for percutaneously remove the recovery filter or facilitate the retrieval of foreign objects from the peripheral vascular system.

    FDA Recall
    Terminated ·Bard Peripheral Vascular Inc·Product code GAE·May 9, 2008

    Shelf Pack: Bard-Parker Rib-Back Stainless Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code GES·August 10, 2007

    Shelf Pack: Bard-Parker Rib-Back Carbon Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code GES·August 10, 2007

    Merit Medical Systems, Inc. Futura Safety Scalpels, Futura Safety Scalpel REF/CAT No SMS210 Used for cutting tissue in surgical and laboratory procedures.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code GES·September 29, 2009