Events

Recall of Device Recall TLS Surgical Drainage System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Leibinger GmbH & Co. KG.

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
    76146
  • Event Risk Class
    Class 2
  • Event Number
    Z-1149-2017
  • Event Initiated Date
    2017-01-03
  • Event Date Posted
    2017-02-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-07-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152296
  • 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
    Apparatus, suction, single patient use, portable, nonpowered - Product Code GCY
  • Reason
    An incorrect sterility status on the label, non-sterile products labeled as sterile.
  • Action
    Stryker sent an " URGENT MEDICAL DEVICE RECALL" notifications dated January 3, 2017, to the affected customers. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, instructions for returning affected product, and instructions for responding to the formal recall notification. Please report any adverse events or product quality problems to Stryker CMF Customer Service: 1 (800) 962-6558.

Device

Device Recall TLS Surgical Drainage System
  • Model / Serial
    Part # 6630 QUINTUBE Monitor Pack Lots-  M1305008, M1305009, M1305010, M1305011, M1309004, M1309005, M1309006, M1309007, M1309008, M1309009, M1309010, M1607009, M1607010, T1309003  Part # 6649 SPG Bulb Drain System, 4mm Flat w/Center Holes Lot - M1508003
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Australia, Canada, Chile, Spain, South Africa and Taiwan.
  • Product Description
    QUINTUBE Monitor Pack (5 tubes/pk, 24 pk/case) (Non-Sterile) || SPG Bulb Drain System, 4mm Flat w/Center Holes (Sterile) || Accessories to TLS Surgical Drainage System
  • Manufacturer
    Stryker Leibinger GmbH & Co. KG

Manufacturer

Stryker Leibinger GmbH & Co. KG
  • Manufacturer Address
    Stryker Leibinger GmbH & Co. KG, Botzinger Strasse 41, Freiburg Germany
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA