Events

Rappel de Device Recall ROTICULATOR Single Use Stapler

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 Covidien LP.

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
    61942
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1846-2012
  • Date de mise en oeuvre de l'événement
    2012-05-09
  • Date de publication de l'événement
    2012-06-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-02-12
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109532
  • 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
    Staple, implantable - Product Code GDW
  • Cause
    Potential for the sterility barrier to be compromised.
  • Action
    The firm, Covidien, sent an "URGENT MEDICAL DEVICE RECALL" letter dated May 16, 2012 via federal express to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately identify and quarantine all affected inventory (note: units from affected lots may have been incorporated into Covidien BEST PRACTICE KITS; evaluate kits for affected lots). All affected ROTICULATOR units must be returned. The customers were also instructed to complete and return the attached ROTICULATOR Single Use Stapler Recalled Product Return form via fax to: (800) 895-6140 or email to: SDFeedback@Covidien.com, even if you do not have any of the affected units, and include a copy of completed form with products being returned. Customers who received product directly from Covidien should contact Covidien Customer Service at SDFeedback@Covidien.com or (800) 722-8772, option 1, prior to returning affected products to Covidien, Field Returns Department, at 195 McDermott Road, North Haven, CT 06473; if received from distributor, return form and contact distributor directly. If you have any questions or concerns, please do not hesitate to contact Covidien Representative or Covidien Quality Assurance at (203) 492-5232.

Device

Device Recall ROTICULATOR Single Use Stapler
  • Modèle / numéro de série
    LOT #'s BEGINNING WITH THE FOLLOWING LETTER/NUMBER COMBINATIONS  P7E P8B P8L P9H POE PIB PIL P7F P8C P8M P9J POF PIC PlM P7G P8D P9A P9K POG PlD P2A P7H P8E P9B P9L POH PIE P2B0153X P7J P8F P9C P9M POJ PlF P7K P8G P9D POA POK PlG P7L P8H P9E POB POL PlH P7M P8J P9F POC POM PlJ P8A P8K P9G POD PIA PlK Also Best Practice Kits Ref#'s: OOZ0800, OOZ0976, OOZ1401, OOZ1407, OOB0117, OOBOI22 NOTE: THE SPECIFIC LOT NUMBERS LISTED BELOW AND LOT NUMBERS ENDING IN ""RMX" and "RRMX" ARE NOT AFFECTED BY THIS RECALL AND ARE ACCEPT ABLE FOR USE. P2A0194XR, P2B0488XR, P2B0153XR
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide distribution: USA (Nationwide) and countries including; Africa, Argentina, Australia, Belgium, Brazil, Canada, China Costa Rica, CROATIA, Czech Republic,Dominion Republic, ESPA¿A France, Germany, Greece Guadeloupe, Guatemala, Honduras Hong Kong, Hungary, India, Indonesia, Ireland, Italy, Japan, Korea ,Malaysia, Mexico, Peru, Portugal, Puerto Rico, Spain, Sri Lanka, Switzerland, Taiwan , Thailand, and UK.
  • Description du dispositif
    Covidien ROTICULATOR 30-V3 Single Use Stapler || REF# 017619 || The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
  • Manufacturer
    Covidien LP

Manufacturer

Covidien LP
  • Adresse du fabricant
    Covidien LP, 60 Middletown Ave, North Haven CT 06473-3908
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA