Events

Recall of Device Recall CVS Pharmacy Plastic Sesame Street Adhesive Bandages

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

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
    58051
  • Event Risk Class
    Class 2
  • Event Number
    Z-1875-2011
  • Event Initiated Date
    2011-02-21
  • Event Date Posted
    2011-04-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-08-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98116
  • 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
    tape and bandage, adhesive - Product Code KGX
  • Reason
    The bandages are labeled as sterile, but failed sterility testing.
  • Action
    Pharmaplast S.A.E. called the direct account on 2/17/11 and sent a Urgent Medical device recall letter dated 2/21/11 to the direct account via overnight mail, requesting that they examine their inventory for the non-sterile adhesive bandages and quarantine them for return to Pharmaplast via sea freight. The account was instructed to contact their customers concerning the recall and return their stocks of the affected lot, which was done by telephone calls on 2/17/11. For questions regarding this Recall please call 00203-4500264

Device

Device Recall CVS Pharmacy Plastic Sesame Street Adhesive Bandages
  • Model / Serial
    REF CVS 826159, UPC 0 50428 95118 7, lot number 10J10
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution - Including Illinois.
  • Product Description
    CVS Pharmacy Plastic Sesame Street Adhesive Bandages; a sterile, latex free, assorted sizes with multiple designs adhesive bandages; 20 bandages per box, 24 boxes per case; Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Made in Egypt; REF CVS 826159, UPC 0 50428 95118 7 || The device is used to cover and protect wounds.
  • Manufacturer
    Pharmaplast S.A.E.

Manufacturer

Pharmaplast S.A.E.
  • Manufacturer Address
    Pharmaplast S.A.E., Free Zone Factory POB 37, Amria Free Zone, Kafr El Zayat, Gharbia Egypt
  • Source
    USFDA