Events

Recall of Device Recall United States Surgical

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

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
    28998
  • Event Risk Class
    Class 2
  • Event Number
    Z-0958-04
  • Event Initiated Date
    2004-05-05
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-11-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32944
  • 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
    Staple, Implantable - Product Code GDW
  • Reason
    Stapler may clamp without the staples being fired into the tissue.
  • Action
    United States Surgical notiied direct accounts by letter dated 5/5/04. Accounts are requested to inventory and quarantine product for return to USS.

Device

Device Recall United States Surgical
  • Model / Serial
    LOT# P2J507 P2J972 P2K1034 P2K616 P2L334 P2L335 P2L607 P2M694 P2M695 P3A83 P3B307 P3D245 P3D564 P3E236 P3E309 P3F683 P3G300 P3G855 P3H21 P3J263 P3J408 P3J42 P3K13 P3L1011 P3L1012 P3L1133 P3L1134 P3L13 P3L237 P3L447 P3L628 P3L728 P3M558 P3M668 P4A636 P4B176 U2H11 U2H17 U2J01 U2J02
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    Auto Suture TA 30 Reloadable Staplers, Single Patient Use || Ref TA30V3S, V3 (2.5mm) DST Series
  • Manufacturer
    United States Surgical

Manufacturer

United States Surgical
  • Manufacturer Address
    United States Surgical, 195 Mcdermott Rd, North Haven CT 06473-3665
  • Source
    USFDA