BEUDAMED
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    Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures.

    FDA Recall
    Terminated ·Stryker Sustainability Solutions·Product code NLM·November 11, 2016

    Product is Reprocessed Ethicon Bladeless Trocars. Model: 35NLT, 35NST, 35OL

    FDA Recall
    Terminated ·Vanguard Medical Concepts, Inc·Product code NLM·March 17, 2006

    Carter-Thomason II Port Closure System; Model Number(s) CTI-1015P, for use in endoscopic and laparoscopic surgery.

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code NLM·March 20, 2015

    Fios First Entry; 5mm x 100mm and 12mm x 100mm; Model #:CTF03 and CTF73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.

    FDA Recall
    Terminated ·Stryker Sustainability Solutions·Product code NLM·June 1, 2015

    Inlet Medical Suture Passer - Reprocessed Sterile device -- Endoscope and accessories.

    FDA Recall
    Terminated ·Ascent Healthcare Solutions, Inc.·Product code NLM·March 11, 2008

    Enseal TRIO Product Code ETRIO335H, Lot Code: G4TC14, Exp. Date 2012/05

    FDA Recall
    Terminated ·Ethicon Endo-Surgery Inc·Product code NLM·July 9, 2010

    Stryker Sustainability Solutions CB5LT Ethicon Endo-Surgery, Inc. Excel Trocar Sleeve w/Stability Sleeve 5mm x 100mm Reprocessed by Stryker Sustainability Solutions Product Usage: The Reprocessed Ethicon ENDOPATH XCEL Universal Trocar Stability Sleeve is a sterile single patient use device with a radiolucent sleeve. The trocar sleeve contains two seals that accommodate instruments 5mm in diameter. Together, these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar. A stopcock valve is compatible with standard luer lock fitting and provides attachment for gas insufflation and desufflation. The stopcock is in the closed position when it is parallel to the sleeve.

    FDA Recall
    Terminated ·Stryker Sustainability Solutions·Product code NLM·July 10, 2015

    Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopic Trocars12x100mm - Product Usage: Physical Product Description: The Reprocessed Blunt Tip Trocar consists of a radiolucent cannula and obturator sized 12mm in diameter (refer to Figure 1). The Reprocessed Blunt Tip Trocar has an obturator that has a blunt plastic tip that gently moves aside any internal viscera that may be adjacent to the abdominal or thoracic wall. The trocar cannula consists of two seals, an outer integrated removable self-adjusting seal that may accommodate instruments ranging from 5mm to 12mm in diameter, and an internal seal. These seals minimize gas leakage when instruments are inserted or withdrawn through the seal. The stopcock valve provides attachment for gas insufflation and desufflation. The stability plug component, is specific only to the H12LP catalog number. The stability plug (adjustable plug) is placed on the outside of the trocar sleeve (cannula). The stability plug provides suture clips (suture anchors), which can be used to suture the Trocar sleeve in place. Intended Use: Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures. Physical Product Description: The Reprocessed Blunt Tip Trocar consists of a radiolucent cannula and obturator sized 12mm in diameter (refer to Figure 1). The Reprocessed Blunt Tip Trocar has an obturator that has a blunt plastic tip that gently moves aside any internal viscera that may be adjacent to the abdominal or thoracic wall. The trocar cannula consists of two seals, an outer integrated removable self-adjusting seal that may accommodate instruments ranging from 5mm to 12mm in diameter, and an internal seal. These seals minimize gas leakage when instruments are inserted or withdrawn through the seal. The stopcock valve provides attachment for gas insufflation and desufflation. The stability plug component, is specific only to the H12LP catalog number. The stability plug (adjustable plug) is placed on the outside of the trocar sleeve (cannula). The stability plug provides suture clips (suture anchors), which can be used to suture the Trocar sleeve in place. Intended Use: Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures.

    FDA Recall
    Terminated ·Stryker Sustainability Solutions·Product code NLM·June 19, 2018

    Cannula and Seal; 5mm x 100mm and 12mm x 100mm Model #: CTS02 and CTS22. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.

    FDA Recall
    Terminated ·Stryker Sustainability Solutions·Product code NLM·June 1, 2015

    AutoSuture Bladed Trocar, equipped with safety shield. Model number 179094. Available with smooth or threaded sleeve in sizes 5-15mm inner diameter and 70-100mm length.

    FDA Recall
    Terminated ·Ascent Healthcare Solutions, Inc.·Product code NLM·October 19, 2006

    Optical Access System; 5mm x 100mm and 12mm x 100mm; Model #: CTR03 and CTR73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.

    FDA Recall
    Terminated ·Stryker Sustainability Solutions·Product code NLM·June 1, 2015

    - ENDOPATH Resposable Bladeless Trocar, Non-Handled, w/Housing, 100mm, (Green) 10/11mm Ref. 511NA Lot 123215, 122647 - ENDOPATH Resposable Bladeless Trocar, Non-Handled, w/Housing, 100mm, (Orange) 5.0mm Ref. 35LNA Lot 123215, 122647 - ENDOPATH Resposable Trocar w/Dilating Tip Obturator & Housing, 100mm, (Orange) 5mm Ref. 35LDA Lot 122647 - ENDOPATH Resposable Trocar, Dilating Tip w/Housing, 100mm, (Purple) 10/12mm Ref. 512DA Lot 123215 - ENDOPATH Sleeve Housing (Orange) 5mm Ref. 355HR Lot 123215, 122647 Endoscope and accessories - ENDOPATH Trocar, Disposable Sleeve Housing, (Green) 10/11mm Ref. 511HR Lot 122647 - ENDOPATH Blunt Tip Obturator & Housing, w/Olive Plug, 100mm, (Purple) 10/12mm Ref. 512BA Lot 122647 - ENDOPATH Resposable Trocar w/ Dilating Tip Obturator & Housing, 100mm, (Green) 10/11mm Ref. 511DA Lot 122454, 122647 - ENDOPATH, Bladeless Trocar with Stability Sleeve, Non-handled 10/12mm Ref. 512NT Lot 123254 - ENDOPATH Xcel Bladeless Trocar, Handled, w/Stability Sleeve, (Teal) 11mm x 100mm Ref. 811LTH Lot 122300 - ENDOPATH Xcel Bladeless Trocar, w/Stability Sleeve 12mm x 150mm Ref. B12XT Lot 122300 - ENDOPATH Xcel Bladeless Trocar, w/Stability Sleeve 5.0mm x 150mm Ref. B5XT Lot 122429 - ENDOPATH Xcel Bladeless Trocar, w/Stability Sleeve, (Teal) 11mm x 100mm Ref. B11LT Lot 122454, 123254, 122429 - ENDOPATH Xcel Bladeless Trocar, w/Stability Sleeve, 100mm Length 5.0mm Ref. B5LT Lot 122347, 122454, 122592, 122490, 123254, 122429, 122300 - ENDOPATH Xcel Bladeless Trocar, w/Stability Sleeve, 75mm Length, (Teal) 5.0mm Ref. B5ST Lot 123254 - ENDOPATH Xcel Blunt Tip Trocar, w/Smooth Sleeve & Adjustable Plug, (Purple) 12mm x 100mm Ref. H12LP Lot 122338, 122372, 123254, 123215 - ENDOPATH Xcel Dilating Tip Trocar, w/Stability Sleeve, (Gold) 11mm x 100mm Ref. D11LT Lot 122454 - ENDOPATH Xcel Dilating Tip Trocar, w/Stability Sleeve, (Gold) 12mm x 100mm Ref. D12LT Lot 122454 - ENDOPATH Xcel Dilating Tip Trocar, w/Stability Sleeve, (Gold) 5.0mm x 100mm Ref. D5LT Lot 122338, 122454, 122490, 122429 - ENDOPATH Xcel Integrated Stability Trocar Sleeve 11mm x 100mm Ref. CB11LT Lot 122429 - ENDOPATH Xcel Integrated Stability Trocar Sleeve 12mm x 100mm Ref. CB12LT Lot 122490 - ENDOPATH Xcel Integrated Stability Trocar Sleeve 5.0mm x 100mm Ref. CB5LT Lot 122490, 122429, 122300 - Kii Optical Access System Threaded (Blue) 5mm x 100mm Ref. C0Q04 Lot 122609

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

    Alm Prismatic Surgical Light 5004 SF; Maquet SA. ALM PRISMATIC (PRC) Surgical Lights are used to provide visible illumination for the surgical field or for the examination of the patient. PRC is designed to eliminate shadow, reduce reflected heat, and illuminate surgical incisions of all depths during surgical procedures.

    FDA Recall
    Terminated ·MAQUET Inc.·Product code FTD·February 23, 2009

    ALM Prismatic Surgical Light 9551 DF; Maquet SA. ALM PRISMATIC (PRC) Surgical Lights are used to provide visible illumination for the surgical field or for the examination of the patient. PRC is designed to eliminate shadow, reduce reflected heat, and illuminate surgical incisions of all depths during surgical procedures.

    FDA Recall
    Terminated ·MAQUET Inc.·Product code FTD·February 23, 2009

    Triathlon PKR Insert X3 #1 LM/RL - 8mm, 5630-G-108, Lot code NXDMEE Triathlon PKR Insert X3 #1 RM/LL - 12mm, 5630-G-122, Lot Code M8JMEE Intended Use: - Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis - Revision of previous unsuccessful surgical procedures, either involving, or not involving, previous use of a unicompartmental knee prosthesis - As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis, where bone stock is of poor quality or inadequate for other reconstructive techniques as indicted by deficiencies of the femoral condyle/tibia plateau. These components are intended for implantation with bone cement. Stryker Orthopaedics; Howmedica Osteonics Copr. 325 Corporate Drive Mahwah, NJ 07430

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code HRY·November 25, 2008

    Bulk Loader Module for cobas p 512/612 Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis. In vitro diagnostic machine component.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·November 25, 2015

    Philips Xcelera Connect, Software R2.1 L 1 SP2, an interface engine for data exchange. Philips Xcelera Connect R2.x is a generic interface and data mapping engine between a Hospital Information System (HIS), Imaging Modalities, Xcelera PACS and Xcelera Cath Lab Manager (CLM). This interface engine simplifies the connection by serving as a central point for data exchange. The data consists only of demographic patient information, schedules, textual information and text reports.

    FDA Enforcement
    Class II ·Terminated·Philips Healthcare Inc.·July 11, 2012

    ALM XTEN Surgical Light intended to provide visible illumination for the surgical field or for the examination of the patient. Part Numbers: ARD567801093, ARD567801094

    FDA Recall
    Terminated ·GETINGE US SALES LLC·Product code FSY·November 16, 2017

    ALM XTEN Surgical Light intended to provide visible illumination for the surgical field or for the examination of the patient. Part Numbers: ARD567801093, ARD567801094

    FDA Enforcement
    Class II ·Terminated·GETINGE US SALES LLC·May 30, 2018

    Bulk Loader Module for cobas p 512/612 Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis. In vitro diagnostic machine component.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code JQP·September 22, 2015