| 30 Oct 2019 | HUDSON RCI SHERIDAN SHERI-BRONCH Endobronchial Tube REF 5-16135 - Product Usage: The Sheridan Endobronchial Tubes are intended for use in Thoracic surgery, brochospirometry, adminitration of endobronchial anesthesia and other uses commonly requiring endobronchial intubation. The Sheridan Endobronchial tube is… | Device | Class II | 1 | Terminated |
| 8 Oct 2019 | Arrow EZ-IO Intraosseous Vascular Access System 15mm Needle+Stabilizer Kit, Product Code 9018P-VC-005 - Product Usage: The Arrow EZ-IO Intraosseous Vascular Access System provides intraosseous access in the proximal humerus, proximal tibia, and distal tibia of adult and pediatric patients, and the distal femur in… | Device | Class II | 3 | Ongoing |
| 4 Oct 2019 | WECK AutoEndo5, Automatic Hem-O-Lok Clip Applier, REF AE05ML Automatic Endoscopic Surgical Ligating Clip Appliers are delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips | Device | Class II | 2 | Ongoing |
| 30 Jul 2019 | Hudson RCI Sheridan LTS: a) 4.0 mm, REF 5-11108 b) 5.0 mm, REF 5-11110 c) 6.0 mm, REF 5-11112 Product Usage: Tracheal tube/airway management | Device | Class I | 8 | Terminated |
| 1 Jul 2019 | Rusch EasyCath Kit | Device | Class II | 1 | Terminated |
| 24 May 2019 | Hudson RCI Sheridan LTS, Product Code 5-11112 Product Usage: Tracheal tube/airway management | Device | Class I | 8 | Terminated |
| 10 May 2019 | Teleflex HUDSON RDI NEONATAL ConchaSmart Breathing Circuit with Dual Heated Limb and ConchaSmart Column: a) REF 870-07KIT b) REF 870-09KIT Product Usage: The Neonatal ConchaSmart breathing circuits are intended to deliver humidified breathing gases for administration to an infant/neonate patient. These gases may be… | Device | Class I | 1 | Terminated |
| 1 Apr 2019 | RUSCH LASERTUBE (Rubber), Order No. : 102004-000040, REF 102004, SIZE I.D. mm 4,0 | Device | Class II | 5 | Terminated |
| 27 Feb 2019 | Teleflex MEDICAL RuSCH One piece Male External Regular Catheter W/O Tape, REF A1500 | Device | Class III | 2 | Terminated |
| 14 Jan 2019 | RUSCH CARE Premium Drain bag, 2000mlm REF 390000 urine collection device | Device | Class III | 2 | Terminated |
| 7 Jan 2019 | Pilling COOLEY SUMP-SUCTION TUBE, REF 351547 | Device | Class II | 1 | Terminated |
| 15 Feb 2018 | Teleflex MEDICAL WECK Visistat 35. Used for the external skin closure of lacerations. | Device | Class II | 1 | Terminated |
| 3 Jan 2018 | Percuvance(R) Percutaneous Shaft 29cm, PCVSH3 The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate Intended Use: soft tissue to access certain areas of the abdomen. The system is used to grasp, manipulate, cut, cauterize and deliver Hem-o-lok ligating clips to soft tissue… | Device | Class II | 2 | Terminated |
| 18 Oct 2017 | Teleflex(R) Percuvance(TM) Percutaneous Surgical System, Components: (a) 5 mm Atraumatic Johans Grasper, Catalog Number PCVJG5 (b) 5 mm Maryland Dissector, Catalog Number PCVMD5 (c) 5 mm Hem-o-lok Clip Applier, Catalog Number PCVHCA5 (d) 5 mm Traumatic Gripper Grasper, Catalog Number PCVGG5 (e) 5 mm Scissors, Catalog… | Device | Class II | 1 | Terminated |
| 5 Oct 2017 | WECK(R) from TELEFLEX Auto Endo5(R), Automatic Hem-o-lok(R) Clip Applier, REF AE05ML (IPN010797) Rx ONLY, STERILE EO | Device | Class II | 1 | Terminated |
| 19 Jul 2017 | Percuvance Gripper Grasper Tool Tip The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the abdomen. The system is used to grasp, manipulate, cut, cauterize and deliver Hem-o-lok ligating clips to soft tissue during laparoscopic surgery. | Device | Class II | 6 | Terminated |
| 5 Jul 2017 | LMA(TM) MADgic(TM) Laryngo-Tracheal Mucosal Atomization Devices: (a) MAD600 MADgic, (b) MAD700 MADgic, (c) MAD720 MADgic Intended for the application of topical anesthetics to the oropharynx and upper airway region | Device | Class II | 1 | Terminated |
| 11 May 2017 | Sheridan SHER-I-SLIP and SOFT-TIP Intubating Stylets are intubating stylets manufactured from galvanized carbon steel and aluminum rods that are coated with a blue PVC or polypropylene outer covering and are designed to be placed inside an endotracheal tube to obtain a desired shape during intubation. | Device | Class II | 1 | Ongoing |
| 9 May 2017 | Hudson RCI, Pediatric Nasal Cannula, Non-Flared Prongs, Rx only, | Device | Class II | 1 | Terminated |
| 21 Apr 2017 | PE CONNECTOR 3/8 STRAIGHT 20/BX, Sterile, Single use, Product Usage: Catheter Connector/Accessory | Device | Class II | 4 | Terminated |
| 29 Mar 2017 | Arrow EZ-IO Needle Set 45 mm 15 ga, Ref 9079. | Device | Class III | 1 | Terminated |
| 24 Mar 2017 | WECK Visistat 35R Disposable Skin Stapler, Ref 528135, Rx Only, Sterile EO, Visistat is indicated for the external skin closure of lacerations on the outer layer of the dermis for a wide range of general, thoracic, obstetric, gynecological, orthopedic, cardiovascular, urological, and plastic surgical procedures | Device | Class II | 1 | Completed |
| 13 Jan 2017 | Teleflex Green Non-Latex Robertazzi Nasopharyngeal Airway, Catalog No. 123130 and 123132 Product Usage: To provide a patent airway for a patient with a blockage or potential blockage of the nasal cavity or nasopharynx. | Device | Class II | 1 | Terminated |
| 10 Jan 2017 | Rusch Greenlite MAC 1, Catalog Number 004551001. Used during tracheal intubation. | Device | Class II | 1 | Terminated |
| 22 Nov 2016 | RUSCH, Pocket PAC IC Intermittent Cath Kit, 8 FR, 12 FR, 14 FR, 10 FR and 16 FR, Rx Only, Sterile, Intermittent self-catheterization | Device | Class II | 1 | Terminated |
| 18 Nov 2016 | WECK Visistat 35W, Disposable Skin Stapler, Rx Only, Sterile, Teleflex Medical, NC 27709. The intended use of the Visistat stapler is to close lacerations on the outer layer of the dermis for a wide range of general, thoracic, obstetric, gynecological, orthopedic, cardiovascular, urological, and plastic surgical… | Device | Class II | 1 | Terminated |
| 16 Nov 2016 | Weck Facial Closure Systems have application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites. | Device | Class II | 1 | Terminated |
| 8 Nov 2016 | ARROW OnControl Bone Marrow Biopsy System Tray, Sterile, Rx only, Manufactured for: Teleflex Medical, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow¿ OnControl Bone Marrow Biopsy System is intended for bone marrow… | Device | Class II | 5 | Terminated |
| 27 Oct 2016 | LMA MADomizer, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is… | Device | Class II | 7 | Terminated |
| 18 Oct 2016 | Sheridan/CF, Cuffed Tracheal Tube, Catalog # 5-10114 and Sheridan/HVT Cuffed Tracheal Tube, Catalog # 5-10315 A tracheal tube is inserted into a patients mouth or nose for airway management | Device | Class II | 1 | Terminated |
| 9 Sep 2016 | Teleflex Percuaneous Solutions, Gripper Grasper, Ref ML003EE, Rx Only Sterile Manufactured for: Teleflex Medical, Park, NC 27709 The Percutaneous Surgical System with 5 mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the human abdomen and used to grasp, hold and… | Device | Class II | 2 | Terminated |
| 26 Aug 2016 | Willy Rusch GmbH Tracheostomy Tube Set Cannulation of tracheotomised patients, particularly in the case of a narrow tracheostoma and narrow-lumen tracheas. When using cannulas with curr. For short term intermittent inflation. | Device | Class I | 1 | Terminated |
| 24 Aug 2016 | WECK¿ Horizon" Manual-Load Ligating Clip Applier, For Medium-Large Size Horizon Ligation Clips Curved Jaw, 11 (28cm), Rx Only, REF 337111, Product Usage: Weck Closure Systems applier has been designed and calibrated for use with specific Horizon, Hemoclip Plus Hemoclip Traditional, or Atrauclip ligating clips as… | Device | Class II | 1 | Terminated |
| 5 May 2016 | Sterile Sheridan/HVT Cuffed, Murphy Eye, Tracheal Tube, Ref: V5-10314, ID: 7.0 mm, Rx Only, Manufactured by: Teleflex Incorporated. A tracheal tube is inserted into a patients mouth or nose for airway management. | Device | Class II | 1 | Terminated |
| 30 Mar 2016 | Pleur-evac Chest Drainage System, Dry Suction/Dry Seal Control, REF A-6000-08LF, Rx Only, Teleflex Medical. Product Usage: Pleur-Evacs are sterile, single-use, chest drainage systems intended for post-operative use | Device | Class II | 1 | Terminated |
| 24 Mar 2016 | Weck EFx Classic Fascial Closure System, Rx Only, Sterile, The product is intended to facilitate placement and withdrawal of suture loops to repair port side defects following laparoscopic surgery | Device | Class II | 1 | Terminated |
| 2 Feb 2016 | Auto Endo5 Hem-o-lok Automatic Clip Applier, Medium Large Polymer Clips, Rx Only, Sterile, REF 543965 Product Usage: The Weck Auto Endo5 hem-o-lok ML automatic endoscopic ligating clip appliers are indicated for use as delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips. These appliers are… | Device | Class II | 1 | Terminated |
| 3 Dec 2015 | MAQUET Servo Humidifier 163, Inmed Mfg. Sdn. Bhd. Lot PT 2577, Jalan Perusahaan, 4, 34600 Kamunting, Perak, Malaysia. | Device | Class II | 1 | Terminated |
| 3 Dec 2015 | Servo Humidifier 163, Model 01-06-8125-8, REF 6419365 Product Usage: A heat and moisture condenser (artifical nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the trachea) to warm and humidity gases breathed in by the… | Device | Class II | 1 | Terminated |
| 14 Oct 2015 | Taut Intraducers 10/BX7.5 FR 3.5, Product Code PI-93. To provide an access port into the peritoneal cavity. | Device | Class II | 1 | Terminated |
| 24 Aug 2015 | R¿sch Flexi-Slip Endotracheal Tube Stylet with Soft Distal Tip, Sterile, Rx only, Teleflex Medical. | Device | Class II | 2 | Terminated |
| 1 Jun 2015 | HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Left sided), Sizes: 28 Fr., 35 Fr., 37 Fr., 39 Fr. and 41 Fr., Rx Only, Sterile. Intended for use in thoracic surgery, bronchospirometry, for the administration of bronchial anesthesia and other uses commonly requiring bronchial intubation. | Device | Class I | 4 | Terminated |
| 14 May 2015 | Lifesaver Single Patient Use Manual Resuscitator Product Usage: The Hudson RCI Lifesaver Single Patient Use manual resuscitator with pressure monitoring port is a disposable medical device intended for use on patients requiring temporary augmentation of ventilation with or without supplemental oxygen delivery during… | Device | Class I | 1 | Terminated |
| 1 Apr 2015 | Teleflex Medical Hudson RCI ConchaTherm Neptune Heated Humidifier, Rx Only. | Device | Class II | 1 | Terminated |
| 13 Mar 2015 | Pluer-evac Sahara Chest Drainage System, S-1100-08LF, Dry Suction/Dry Seal Control, Rx Only, Teleflex Medical. | Device | Class II | 1 | Terminated |
| 14 Jan 2015 | Hudson RCI¿ Humidifier Adaptor, 040 contained in the following units: HUMIDIFIER ADAPTOR 040 Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier… | Device | Class II | 15 | Terminated |
| 13 Jan 2015 | LMA (Laryngeal Mask Airway) Supreme (New Cuff) Size 5, Sterile, Single use, Product Usage: Achieve and maintain control of airway during routine anaesthesia in fasted patient using either spontaneous or positive pressure ventilation, cardiopulmonary resuscitation, the failed intubation situation and the… | Device | Class II | 1 | Terminated |
| 12 Jan 2015 | MAQUET, SERVO Humidifier 163, Rx Only, Inmed Mfg. Sdn Bhd. Catalog No: XKC01-06-8125-8, Model No. 01-06-8125-8. A heat and moisture condenser (artificial nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the trachea) to… | Device | Class I | 1 | Terminated |
| 9 Jan 2015 | Hudson RCI, Sheridan, Preformed Tracheal Tubes, Cuffed and Uncuffed, Rx Only, Sterile, Teleflex Medical. | Device | Class II | 1 | Terminated |
| 8 Jan 2015 | Pilling Modular Verres Body/Obturator, Product Code 140880 | Device | Class II | 1 | Terminated |
| 3 Dec 2014 | WECK Hemoclip¿ Traditional Medium Tantalum Ligating Clips. Weck Ligating Clips are intended for use in procedures involving vessels or anatomic structures for which the surgeon determines ligating clips are the best choice. | Device | Class II | 1 | Terminated |
| 12 Nov 2014 | Sheridan/CF Cuffed Tracheal Tube, Sterile, Rx only, Teleflex Medical, Research Triangle Park, NC 27708. Designed for oral and nasal intubation and are indicated for airway management. | Device | Class II | 1 | Terminated |
| 26 Sep 2014 | Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle. | Device | Class II | 1 | Completed |
| 8 Sep 2014 | Hudson RCI¿ Pediatric Anesthesia Breathing Circuits, Single Patient Use, Rx Only, Product Usage: To administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Ypiece. | Device | Class I | 1 | Terminated |
| 4 Sep 2014 | Rusch, Soft Rubber (Nelaton and Nelaton Robinson), Bladder Catheter, Sterile. These catheters are indicated for the routine drainage of urine from the bladder. These catheters are not intended or designed for indwelling use. | Device | Class II | 1 | Terminated |
| 3 Sep 2014 | Aquapak Adaptor, 028 NEB, INTL, Product No. 403128; Aquapak Adaptor, 033 NEB, INTL, Product No. 403133; Aqaupak Nebulizer Adaptor 028, Sterile, Shelfpak, Product No. 031-28 & 031-28F, Aqaupak Nebulizer Adaptor 033, Sterile, Shelfpak, Product No. 031-33; Aqaupak Nebulizer Adaptor 033, Sterile, Japanese, Product No.… | Device | Class II | 2 | Terminated |
| 10 Jul 2014 | RUSCH Foley Urinary Catheter Insertion Tray with 10cc syringe, BZK Swabs, Sterile, Rx only, Teleflex Medical Product Code: 76730. | Device | Class III | 1 | Terminated |
| 9 Jul 2014 | Emerald Fiberoptic Blade, Macintosh 4, Teleflex Medical. A rigid laryngoscope is a device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube. | Device | Class II | 1 | Terminated |
| 9 Jul 2014 | Hudson RCI, Breathing Circuit, Adult, Single Limb w/Heated Wire, [Respiratory Gas Humidifier, (Direct Patient Interface)]. The Hudson Heated Wire Ventilator Circuit is intended as a conduit for respiratory gas between a patient and a ventilator, and includes heated wires for use with a Concha Column Humidifier. | Device | Class II | 2 | Terminated |
| 30 Jun 2014 | RUSCH, TruLite, One-Piece Disposable Laryngoscope Handle Blade Combination, Non-Sterile, Rx Only, Distributed by: Teleflex Medical. | Device | Class II | 1 | Terminated |
| 5 Jun 2014 | Aquapak 340 SW, 340, mL w/040 Adaptor, International, Teleflex Medical, respiratory gas humidifier adaptor . | Device | Class II | 15 | Terminated |
| 23 May 2014 | RUSCH, LaserTube (Rubber), Laser Resistant Tracheal Tube, cuffed, Teleflex Medical, Willy-Rusch, GmbH. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway. | Device | Class II | 1 | Terminated |
| 21 May 2014 | RUSCH Easy Cath Coude Kit, 10 FR, Rx Only, Sterile, Distributed by: Teleflex Medical, Research Triangle Park, NC 27708. A tubular device that is inserted through the urethera and is used to pass fluids to or from urinary tracts. | Device | Class II | 1 | Terminated |
| 16 May 2014 | Taut Operative Cholangiogram Catheter, 4.5FR (1.5mm) x 76cm To facilitate the introduction of contrast media into the biliary ducts to obtain a cholangiogram during laparoscopic or open cholecystectomy. | Device | Class II | 1 | Terminated |
| 17 Apr 2014 | Hudson RCI Adult Universal Ventilator Circuit, Duel Heated Limb and Hudson RCI Adult Heated Wire Circuit Kit with Column | Device | Class II | 1 | Terminated |
| 11 Mar 2014 | Monofilament and Multifilament Non-absorbable Steel Suture; Product Codes: 0520197-2, 29-727, 29-7270M4, 29-7281M4, E29-5553M4, E29-7270M4, E29-7272M4, E29-727A, EP4013P, EP4110N, X-2235, X29-7271M2, X-5667M8 and X-6730M5. | Device | Class II | 1 | Terminated |
| 11 Mar 2014 | Weck¿ Vista", Universal Laparoscopic Port, Size 5/10mmx100mm, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. | Device | Class II | 15 | Terminated |
| 11 Mar 2014 | Monodek Violet Synthetic Absorbable Surgical Sutures, MF 0 TC43/HR26 48 | Device | Class II | 1 | Terminated |
| 11 Mar 2014 | Nonabsorbable Surgical Suture, U.S.P., Sterile - Do Not Resterilize, Deknatel. Indicated for use in soft tissue approximation. | Device | Class II | 7 | Terminated |
| 11 Mar 2014 | Suture, Non-absorbable, Synthetic, Polyamide, Sterile, Rx only, Product Usage: Non-absorbable polyamide surgical suture is a non-absorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation. | Device | Class II | 6 | Terminated |
| 11 Mar 2014 | Weck Vista Universal Laparoscopic Port, Size 5/10mm x 100mm, Catalog No. 405910, Weck Vista Universal Laparoscopic Port, Size 5/10/12mm x 100mm, Catalog No. 405912; Weck Vista Universal Laparoscopic Port, Size 5/10/12mm x 125mm, Catalog No. 40591213. An endoscope and accessories is a device used to provide access,… | Device | Class II | 6 | Terminated |
| 11 Mar 2014 | CAPIO, Monodeck, Violet Monofilament Polydioxanone Suture, 1 x 48 inches (122cm) Absorbable Surgical Suture, Rx Only, Teleflex Medical. Product Code: 833-137. | Device | Class II | 2 | Terminated |
| 4 Mar 2014 | Sengstaken Tube and Sengstaken-Blakemore Tube. Teleflex product codes 204800, 204802, and 204803, a gastrointestinal tube and accessories, consisting of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. | Device | Class II | 1 | Terminated |
| 28 Feb 2014 | Rusch Brochopart and Rusch Brochopart White The Rush Endobronchial Tube set is indicated for uses commonly associated with oral endobronchial tubes, including, but not limited to, thoracic surgery, bronchospirometry, administration of endobronchial anesthesia, etc. The endobronchial tube allows ventilation and… | Device | Class II | 1 | Terminated |
| 6 Jan 2014 | ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 6.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway. | Device | Class I | 14 | Terminated |
| 19 Dec 2013 | Weck, Electrosurgical Coagulation Suction Tube 6 (15.2cm), 11 French, with Stylet, Teleflex Medical, Research Triangle, NC 2770. Intended to remove tissue and control bleeding by use of high-frequency electrical current. | Device | Class II | 2 | Terminated |
| 15 Oct 2013 | Green Rusch - Lite Disposable Metal Laryngoscope Ridge Blade to visualize upper airway and aid in placement of tracheal tube. | Device | Class II | 1 | Terminated |
| 8 Aug 2013 | Horizon 24 Large Titanium Clips with Adhesive Backing, Ref 004204, Rx Only, Sterile. The metal ligating clips are intended for use in procedures involving vessels or anatomic structures for which the surgeon determines ligating clips are the best choice. An implantable clip is a clip-like device intended to connect… | Device | Class II | 1 | Terminated |
| 28 Mar 2013 | Belly Bag Urine Collection Bag with Hip Belt. The product is a sterile urine collection device that collects urine by mechanical means when attached to an indwelling Foley or suprapubic catheter. | Device | Class II | 1 | Terminated |
| 25 Sep 2012 | Hem-o-lok Large Polymer Ligating Clips, REF #544240, Rx only, Sterile, Teleflex Medical, Research Triangle Park, NC 27709. Teleflex Medicals Hem-o-lok polymer ligating clips are single use, sterile, non-absorbable medial devices that have been designed to ligate vessels and tissue structures during various types of… | Device | Class II | 1 | Terminated |
| 20 Jul 2012 | TAUT, Cholangiogram Catheter Intraducer, Peritoneal Catheter, Teleflex Medical, Research Triangle Park, NC. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. | Device | Class III | 1 | Terminated |
| 12 Jun 2012 | Hudson RCI Concha Therm Neptune Humidifier, Rx Only, Product Usage: Usage: Device that is intended to add moisture to, and sometime to warm, the breathing gases for administration to a patient. | Device | Class II | 1 | Terminated |