Events

Rappel de Convenience Kit

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 Merit Medical Systems, Inc.

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
    30119
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0050-05
  • Date de mise en oeuvre de l'événement
    2004-09-14
  • Date de publication de l'événement
    2004-10-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2005-03-31
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35209
  • 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
    Catheter, Intravascular, Diagnostic - Product Code DQO
  • Cause
    Certain syringes exhibit a potential for air to be drawn into the syringe due to a dimensional mismatch.
  • Action
    All consignees were notified by telephone and letter on 9/14/2004. A second letter, dated 11/24/04, was also sent to consignees.

Device

Convenience Kit
  • Modèle / numéro de série
    Part No. K07-00116AP, Lot Nos A340949, A346191. Part No. K09-00302FP, Lot # A340485, A341488 Part No. K09-00579CP, Lot # A339214, A345673 Part No. K09-00585LP, Lot # A338201, A344694 Part No. K09-00759DP, Lot #A342359, A345674,   A347263. Part No. K09-00946MP, Lot # A341491 Part No. K09-00970K, Lot # A337245 Part No. K09-01574G, Lot # A343825 Part No. K09-01673H, Lot # A342676 Part No. K09-01908AP, Lot # A338729, A344187,   A344382. Part No. K09-02104HP, Lot # A337839, A346138 Part No. K09-02249H, Lot # A343819 Part No. K09-02249HP, Lot # A339688 Part No. K09-02334K, Lot # A345405 Part No. K09-02353G, Lot # A342675 Part No. K09-03242C, Lot # A342165 Part No. K09-03528D, Lot # A341710 Part No. K09-03978HP, Lot # A339229, A340896,  A344386. Part No.K09-04000HP, Lot # A338208, A339231,  A341504, A344612,  A341505, A341504. Part No. K09-04017C, Lot # A337857 Part No. K09-04316H, Lot # A342071. Part No. K09-04488A, Lot # A338228, A341118. Part No. K09-04863C, Lot # A337204, A338112. Part No. K09-04863C, Lot # A337204. Part No. K09-04923B, Lot # A340508, A 343196. Part No. K09-05138CP, Lot # A339425, A342802. Part No. K09-05229G, Lot # A339926. Part No. K09-05229GP, Lot # A345552. Part No. K09-05477A, Lot # A342803. Part No. K09-05785DP, Lot # A340897. Part No. K09-05939C, Lot # A337947, A342379. Part No. K09-05947D, Lot # A342670. Part No. K09-06262P, Lot # A341604. Part No. K09-07470C, Lot # A342173. Part No. K09-07547B, Lot # A340375. Part No. K09-07573AP, Lot # A344373. Part No. K09-07573P, Lot # A342349. Part No. K09-07589P, Lot # A347257, A347985. Part No. K09-07629CP, Lot # A344853. Part No. K09-07746A, Lot # A337319. Part No. K09-07759, Lot # A341614.  Part No. K09-07779P, Lot # A344855, A347876. Part No. K09-07847, Lot # A342385. Part No. K09-07883B, Lot # A336474. Part No. K09-07924AP, Lot # A346124. Part No. K09-07943AP, Lot # A345851. Part No. K09-07944A, Lot # A339427. Part No. K09-08020B, Lot # A331903. Part No. K09-08065P, Lot # A345570. Part No. K09-08150AP, Lot # A340352, A342387. Part No. K09-08214B, Lot # A340534 Part No. K09-08369, Lot # A342388. Part No. K09-08391AP, Lot # A340252, A343600. Part No. K09-08397, Lot # A335968. Part No. K09-90270KP, Lot # A3412623, A343596. Part No. K09-90358DP, Lot # A345692. Part No. K09-MS2366H, Lot # A341693. Part No. K09-MS2450B, Lot # A338759. Part No. K09-MS2550A, Lot # A343809. Part No. K09-MS2602A, Lot # A342813. Part No. K09-MS2638B, Lot # A341694, Part No. K09-MS2703B, Lot # A336929, A343808. Part No. K10-01223B, Lot # A339948. Part No. K10-03441P, Lot # A336328, A343551. Part No. K10-03616, Lot # A339959. Part No. K12-01176B, Lot # AS345883.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide. One VA facility in NC, one military hospital in GA. Foreign distribution to Canada, France, Japan, Netherlands.
  • Description du dispositif
    Convenience Kits containing Inject8 or Inject10 syringes.
  • Manufacturer
    Merit Medical Systems, Inc

Manufacturer

Merit Medical Systems, Inc
  • Adresse du fabricant
    Merit Medical Systems, Inc, 1600 Merit Pkwy, South Jordan UT 84095-2416
  • Source
    USFDA