Events

Rappel de Device Recall Sterile Lubricating Jelly

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 H & P Industries, Inc. dba Triad Group.

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
    57612
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0934-2011
  • Date de mise en oeuvre de l'événement
    2010-12-23
  • Date de publication de l'événement
    2011-01-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-06-11
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96796
  • 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
    Lubricant, patient - Product Code KMJ
  • Cause
    Triad group is recalling all lots of sterile lubricating jelly manufactured by triad group. this recall has been initiated due to concerns expressed by the food and drug administration regarding the validation of the gamma radiation sterilization cycles for these products.
  • Action
    The firm, Triad Group, sent an "URGENT MEDICAL DEVICE RECALL" letter dated December 22, 2010, to all customers via US Postal Service certified. The letter described the issue, identified affected product as that which contained a lot number beginning with the digits 7, 8, 9, or 0, and the action to be taken by the customers. The customers were instructed to immediately examine their inventory and quarantine the product subject to recall; notify their customers at once if the recalled product was further distributed, and complete and return the enclosed Recall Acknowledgement form via fax at 262-538-2947 or mail along with the recalled product to: Recall Coordinator, Triad Group, 700 West North Shore Drive, Hartland, WI 53029. If you have any questions, please call Triad Group Customer Service Monday thru Friday, between the hours of 8:30 a.m. and 4:00 p.m. Central Time at 262-538-2900 ext 2761.

Device

Device Recall Sterile Lubricating Jelly
  • Modèle / numéro de série
    all Lot numbers beginning with the digits 7, 8, 9, or 0.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA including states of: CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MA, MI, MO, MS, MY, NC, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI and Puerto Rico; and countries including: Australia, Belgium, Canada, China, Lebanon, New Zealand, Philippines, Northern Marianna Islands, Saudi Arabia, Singapore, Taiwan, and United Arab Emirates.
  • Description du dispositif
    Lubricating Jelly, Sterile, Non-staining, Made in the USA, packaged into the following size containers 5 gram tube, 2 ounce and 4 ounce tubes, 4 ounce bottle, 3 and 5 gram packets || Intended use: A patient lubricant is a device intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device. || Brand names: || 1. Allegiance, Distributed by: Cardinal Health, McGaw Park, IL 60085-6787, USA, Cat. LJT2. Net Wt. 2 oz., Cat. LJF3, Net Wt. 3g, Cat. LJT4, Net Wt. 4 oz., Cat. LJT5, Net Wt. 5 g; || 2. Select medical products, manufactured for PSS World Medical, Inc., 4345 Southpoint Blvd., Jacksonville, FL 32216, Reorder #137, 3 g/packet, Reorder #136, 4 oz.; || 3. Novaplus, Manufactured for Novation, Inc., Irving, TX 75039, Manufactured by: Triad Group, Inc., 700 West North Shore Drive, Hartland, WI 53029, Cat. No. V10-8344, Net Wt. 3 grams, Cat. No. V10-8919, Net Wt. 4 oz., Cat. No. V10-8917, Net Wt. 2 oz.; || 4. Triad Group, Inc., 700 West North Shore Drive, Hartland, WI 53029, || Cat. No. 10-8917, Net Wt. 2 oz, || Cat. No. 10-8946, Net Wt. 5 g, || Triad Plus Cat. No. 11-8344, 3 g., || Cat. No. 11-8472, 5 grams, || Cat. No. 10-8919, Net Wt. 4 oz, || Cat. No. 10-8500, Net Wt. 4 oz; || 5. IMCO, Manufactured for: Independent Medical Co-op, Inc., Daytona Beach, FL 32114. Reorder No. 8919-IMC Net Wt. 4 oz.; || 6. McKesson Medi-Pak Performance, Marketed by McKesson Corporation, McKesson Surgical, Richmond, VA 23228. Reorder No. 66-8919, Net Wt. 4 oz.; || 7. Henry Schein, Distributed by: Henry Schein Inc., Melville, NY 11747. 104-9637, Net Wt. 4 fl. oz.
  • Manufacturer
    H & P Industries, Inc. dba Triad Group

Manufacturer

H & P Industries, Inc. dba Triad Group
  • Adresse du fabricant
    H & P Industries, Inc. dba Triad Group, 700 W North Shore Dr, Hartland WI 53029-8358
  • Source
    USFDA