Rappel de Device Recall HemaSyst, Dual cannula Tip with Adapter 16 ga. x 4" (10.2 cm)

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 Haemacure Corporation.

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
    61636
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1537-2012
  • Date de mise en oeuvre de l'événement
    2009-11-16
  • Date de publication de l'événement
    2012-05-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
  • Date de fin de l'événement
    2012-05-14
  • 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
    Syringe, irrigating (non dental) - Product Code KYZ
  • Cause
    This product has been recalled due to the lot number being different on the box and pouch. the lot number on the box label was incorrectly printed as 11144 instead of 111144. the pouch label referenced the correct lot number, 111144.
  • Action
    Haemacure Corporation, Sarasota, FL initiated letters via e-mail on 11/16/2009 with delivery and read receipt confirmation to their two consignees. The letters identified the affected product and stated the reason for the recall. The letter also states that the firm will replace each order upon receipt of the mislabeled boxes at no charge to the customer. Customers were asked to return their unused devices. Questions should be directed to customer service at 1-877-872-4583.

Device

  • Modèle / numéro de série
    Model H-1604, Lot Number 111144, expiration 10/2014
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution -- Illinois and California.
  • Description du dispositif
    HemaSyst, Dual Cannula Tip with Adapter 16 ga. x 4" (10.2 cm). Product is labeled in part:"***Pouch label***HAEMACURE***HemaSyst***tm***Contents: One ***DUAL CANNULA TIP***WITH ADAPTER***16 ga. x 4" (10.2 cm)***REF H-1604*** CE 0297***LOT 111144***2014/10***40680b/20004-02***CAUTION: U.S. Federal Law restricts this device to sale by or on the order of a licensed physician (or properly licensed practitioner).***Contents of unopened undamaged package are sterile***CE 0297***Manufactured by: ***Micromedics*** St. Paul, MN 55121-1385 USA***Distributed by:***Haemacure Corporation***Sarasota, FL 34236 USA***Toll Free 1-877-872-4583***www.haemacure.com***Box label***Contents: 5 packages of 1 each***DUAL CANNULA TIP***WITH ADAPTER***16 ga. x 4" (10.2 cm)***REF H-1604***CE 0297***STERILE EO***LOT 11144***2014/10***40681B/20544***". || Sterile, single-use instrument for the application of two liquids.
  • Manufacturer

Manufacturer

  • Adresse du fabricant
    Haemacure Corporation, 600 Tallevast Rd, Sarasota FL 34243-3254
  • Source
    USFDA