Rappel de FemSoft Insert, Female Urethral Insert, Size 2 Standard, 3.5 cm Length.

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 Rochester Medical Corp.

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
    55765
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1908-2010
  • Date de mise en oeuvre de l'événement
    2010-04-27
  • Date de publication de l'événement
    2010-06-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
  • Date de fin de l'événement
    2011-12-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
  • 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
    Transurethral occlusion insert, urinal incontinence-control, female. - Product Code OCK
  • Cause
    Rochester medical is voluntarily recalling specific lots of femsoft urethral inserts manufactured and distributed in 2009 and 2010. testing has revealed a small number of packages which contain a small void in the package seal, and it has been determined that product sterility cannot be guaranteed. if product sterility has been compromised, there is a potential for increased risk of urinary trac.
  • Action
    Consignees were contacted by telephone on 5/3/10 and if not reached, were sent a Rochester Medical "Urgent Medical Device Recall" letter on 5/6/10 dated April 26, 2010. The letter was addressed to Rochester Medical Corporation Customers. The letter described the problem and product involved; recommended consignees to record the quantity and lot numbers (s) on the enclosed postcard and return it to them; and to immediately destroy the product with the lots affected. In the case of distributors, the telephone call was followed by a letter sent/dated April 27, 2010 to each distributor. It advised distributors to isolate any remaining inventory with the specified lot numbers and to complete the disposition report. Letters included a customer letter for dissemination to their retail level customers. Retail customers were asked to segregate and destroy the affected products and record the action. The company will replace the destroyed product. The distributors started their contact to consignees on 4/28/10. Please contact Rochester Medical at 1-800-243-3315, or the firm's Customer Service Department at 1-507-533-9309 for additional information or for product return & replacement instructions.

Device

  • Modèle / numéro de série
    REF Lot Pouch 71202 53500521 53500515 71202 53500602 53500601  71202DT 53500566 53500515 71202DT 53500603 53500601
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    AL, AK, AZ, CA, CO, DC, FL, GA, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV, WY, WI,. AUSTRIA, BANGLADESH, CANADA, CYPRUS, ETHIOPIA, FRANCE, GERMANY, GREECE, INDIA, JAPAN, KOREA, NETHERLANDS, P.R. CHINA, SAUDI ARABIA, SCOTLAND, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TURKEY, UAE, UNITED KINGDOM.
  • Description du dispositif
    FemSoft Insert, Female Urethral Insert, Size 2 Standard, 3.5 cm Length, Sterile (R), Rx Only, REF 71202 or 71202DT. || Rochester Medical Corporation, One Rochester Medical drive, Stewartville, MN 55976 USA.
  • Manufacturer

Manufacturer

  • Adresse du fabricant
    Rochester Medical Corp, 1 Rochester Medical Dr Nw, Stewartville MN 55976-1647
  • Source
    USFDA