Events

Rappel de Weck Hemolok XL Polymer Ligating Clips

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Teleflex Medical.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    35316
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1098-06
  • Date de mise en oeuvre de l'événement
    2006-04-12
  • Date de publication de l'événement
    2006-06-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2007-11-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45876
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Polymer Ligating Clips - Product Code FZP
  • Cause
    The hem-o-lok ligating clips may become dislodged following ligation of the renal artery after laparoscopic donor nephrectomy. hem-o-lok ligating clips are now contraindicated for use in ligating the renal artery during laparascopic nephrectomies in living donor patients.
  • Action
    Teleflex Medical sent Important Product Safety Information letters dated 4/18/06 to all of their customers who have purchased Hem-o-lok Ligating Clips from Teleflex. The letters informed the healthcare providers that Teleflex has been made aware of incidents in which the ligating clips (sizes L and XL) were reported to have become dislodged following ligation of the renal artery after laparoscopic donor nephrectomy. Although none of the incidents appear to have involved any defect in or malfunction of the ligating clips, misapplication of the Hem-o-lok clips during such laparascopic procedures may not immediately be apparent and can have serious, even life-threatening consequences post-operatively. Therefore, Teleflex has added the following contraindication to the Instructions for Use accompanying the Hem-o-lok Polymer Ligating Clips: 'Contraindications': Hem-o-lok ligating clips are contraindicated for use in ligating the renal artery during laparoscopic nephrectomies in living donor patients. 'Caution': The clip must be latched to ensure proper ligation of the vessel or tissue. Inspect the ligation site after application to ensure proper closure of the clip. Security of the closure should be confirmed after ligation. The Hem-o-lok Polymer Ligating Clip is not designed for use as a tissue marker. Weck recommends that more than one clip be used to ligate the renal artery in procedures other than laparoscopic donor nephrectomy (see Contraindication, above). Application of more than one clip to all other vessels should be left to the surgeon's judgment.' Any questions concerning the letter were directed to Teleflex Medical at 800-334-9751, option #7, then option #5. Teleflex sent follow-up ¿Important Product Correction Notice¿ letters dated 8/2/06 to all of their Hem-o-lok Ligating Clips customers via registered mail on 8/7/06. The letters provide clarification of the 4/18/06 letter, reinforcing that the clips are contraindicated for use in ligating t

Device

Weck Hemolok XL Polymer Ligating Clips
  • Modèle / numéro de série
    catalog number 544250, all lots
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide
  • Description du dispositif
    Weck Hem-o-lok XL Polymer Ligating Clips; Rx, sterile, extra large size, non-absorbable polymer ligation clips; 6 clips per cartridge, 14 cartridges per sales unit, 12 sales units per case; Mfg. by Weck Closure Systems, Research Triangle Park, NC 27709; REF 544250
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical
  • Adresse du fabricant
    Teleflex Medical, 2345 Waukegan Rd Ste 120, Bannockburn IL 60015-1580
  • Source
    USFDA