Events

Recall of Device Recall Active Life Little Ones OnePiece Custom Urostomy Pouch 5/16 1 inch, 825mm

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by ConvaTec.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    46802
  • Event Risk Class
    Class 3
  • Event Number
    Z-1179-2008
  • Event Initiated Date
    2008-02-14
  • Event Date Posted
    2008-05-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-10-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68293
  • Notes / Alerts
    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.
  • Extra notes in the data
    Ostomy pouch and accessories - Product Code EXB
  • Reason
    Mislabeled: the market unit carton label reads 5/8 - 1 inch, and it should read 5/16 - 1 inch. the metric units (8-25mm) on the label are correct.
  • Action
    Consignees were notified by an Urgent Product Recall Letter on 2/14/08. Updated letters were issued on 2/21/08 and 4/10/08 with expanded lot numbers. The letters instruct users to return any affected products and a product recall response form. For additional information, contact (908) 904-2199.

Device

Device Recall Active Life Little Ones OnePiece Custom Urostomy Pouch 5/16 1 inch, 825mm
  • Model / Serial
    Lot Numbers: 6G4890N, 7C0178N, 7D0529N, 7E1100N, 7F1816N, 7F2009N, 6B2462N, 6E3474N, 6H5767N, 6J5972N and 6L7175N. UPC Code: 30003-020917.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Active Life Little Ones One-Piece Custom Urostomy Pouch 5/16 - 1 inch, 8-25mm; Ostomy pouch and accessories, Product Order Number 020917, Nypro Dominican Republic Inc., ConvaTech, Skillman, NJ 08558
  • Manufacturer
    ConvaTec

Manufacturer

ConvaTec
  • Manufacturer Address
    ConvaTec, 200 Headquarters Park Dr, Skillman NJ 08558-2624
  • Source
    USFDA