Events

Rappel de ARTERIAL CATHETERIZATION 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 Arrow International 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
    57287
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1358-2011
  • Date de mise en oeuvre de l'événement
    2010-10-29
  • Date de publication de l'événement
    2011-02-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-09-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95801
  • 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
    Wire, guide, catheter - Product Code DQX
  • Cause
    Sterility may be compromised.
  • Action
    Arrow International, Inc. sent an URGENT MEDICAL DEVICE RECALL letter dated October 29, 2010, to all affected customers. The letter identified the products, the problem, and the action to be taken by the customer. Customers were instructed to quarantine the product. If they had no affected product in stock, check the appropriate box on the Recall Acknowledgement & Stock Status Form and fax the form to Arrow's Customer Service fax number 800-343-2935. If they had affected stock, immediately quarantine the product and contact Arrow Customer Service at 800-523-8446 for a Return Authorization Number. If customers wished to return product for replacement, they were to consult their sales representative or Arrow Customer Service for information on product availability, substitutability, and lead times. Complete the enclosed Recall Acknowledgement & Stock Status Form and immediately fax the compoleted form to Arrow, Fax number 800-343-2935, Attn: Customer Service. Return any affected product freight collect, along with the original completed Recall Acknowledgement & Stock Status Form to: Arrow International, Inc. 312 Commerce Place Aheboro, NC 27203 Attn: Asheboro Quality Assurance Manager. For any questions regarding this recall call 800-523-8446.

Device

ARTERIAL CATHETERIZATION KIT
  • Modèle / numéro de série
    CC-04100 Lot Numbers: RF0019630, RF0035146, RF0062164, RF0063964, RF4121260, RF5012171, RF5022620, RF5022694, RF5022936, RF5023056, RF5043795, RF5044244, RF5054841, RF5060136, RF5072938, RF5083080, RF5084506, RF5095700, RF5106236, RF5118583, RF6012260, RF6022847, RF6033756, RF6034434, RF6035286, RF6057003, RF6068210, RF6070336, RF6080902, RF6081546, RF6093300, RF6104481, RF6115675, RF6116613, RF6127345, RF6127983, RF7018330, RF7020221, RF7032233, RF7054012, RF7054686, RF7065398, RF7076855, RF7077581, RF7088648, RF7089293, RF7090478, RF7101417, RF7112432, RF7113766, RF7124960, RF8015963, RF8020094, RF8029171, RF8031984, RF8033220, RF8044241, RF8045487, RF8056874, RF8057384, RF8068362, RF8071384, RF8083492, RF8085126, RF8096691, RF8109018, RF8110511, RF8110923, RF8123490, RF9015797, RF9027384, RF9028781, RF9030798, RF9044347, RF9056860, RF9057865, RF9060300, RF9071990, RF9101135, RF9112313, RF9112770, RF9114303 and RF9125231.  FS-04510 Lot Numbers: RF0020943, RF0033155, RF0059261, RF0062162, RF0075661, RF8033219, RF8045501, RF8070634, RF8119793, RF8124055, RF9030633, RF9068315, RF9071039, RF9085981, RF9101233 and RF9126921.  NS-04100 Lot Numbers: RF0021271, RF0035169, RF0059455, RF0062166, RF0076519, RF0087520, RF5012173, RF5012263, RF5022525, RF5022640, RF5022884, RF5033202, RF5043960, RF5044137, RF5044415, RF5054655, RF5055028, RF5060314, RF5072320, RF5084106, RF5095841, RF5106237, RF5107230, RF5118615, RF6011424, RF6012258, RF6022392, RF6033757, RF6034356, RF6045750, RF6057353, RF6057883, RF6068372, RF6068635, RF6070561, RF6079358, RF6080954, RF6081473, RF6082032, RF6093231, RF6104147, RF6116038, RF6116779, RF7018345, RF7020079, RF7029684, RF7031136, RF7031694, RF7042757, RF7043349, RF7054836, RF7066014, RF7066675, RF7077586, RF7088649, RF7089181, RF7090486, RF7101953, RF7102163, RF8015969, RF8016893, RF8029175, RF8031766, RF8033221, RF8044245, RF8045307, RF8057233, RF8068375, RF8072081, RF8083722, RF8097203, RF8107887, RF8111833, RF811833, RF9014775, RF9027307, RF9042699, RF9068374, RF9085995, RF9101133, RF9112853, RF9114302 and RF9125236.  PW-04100 Lot Numbers: RF8029429, RF8031774, RF8043868 and RF8057234.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- United States - all 50 States, and the countries of Canada, South America, China, South Africa, Australia, Puerto Rico, Philippines, Singapore, South Korea, New Zealand, Mexico, Japan, India, Indonesia, Bahamas, Taiwan, Thailand, Finland, France, Cyprus, Czech Republic, Belgium, Germany, Ireland, Italy, Latvia, Netherlands, Poland, Slovakia, Spain, Bahamas, Costa Rico, Dominican Republic, Ecuador, Guatamala and the United Kingdom.
  • Description du dispositif
    ARTERIAL CATHETERIZATION KIT/Product SKU's (Codes) CC-04100, FS-04510, NS-04100 and PW-04100. || Cardiovascular catheterization kit
  • Manufacturer
    Arrow International Inc

Manufacturer

Arrow International Inc
  • Adresse du fabricant
    Arrow International Inc, 2400 Bernville Road, Reading PA 19605
  • Société-mère du fabricant (2017)
    Teleflex Incorporated
  • Source
    USFDA