Events

Recall of Device Recall Simplastic Suprapubic Puncture Instrument

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

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
    79579
  • Event Risk Class
    Class 2
  • Event Number
    Z-1369-2018
  • Event Initiated Date
    2018-03-15
  • Event Date Posted
    2018-04-12
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162687
  • 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
    Catheter, urethral - Product Code GBM
  • Reason
    These products contain latex, but the following statement is not included on any level of product packaging: caution: this product contains natural rubber latex which may cause allergic reactions.
  • Action
    The firm initiated their field correction on 03/15/2018 by letter. The notices stated the following: Affected distributors are instructed to take the following actions: 1. Place a copy of this notification with each unit of affected product currently in your inventory. 2. Using the provided customer letter template and acknowledgment form, communicate this notification to any of your customers who have received product included within the scope of this notification. 3. Have each of your customers who received the affected product return a completed acknowledgment form to you. 4. Once you have finished collecting and consolidating all of the acknowledgment forms, from your customers and placing a copy of this notification with each unit of affected product in your inventory, please complete the enclosed Distributor Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document completion of this recall. Affected direct customers are instructed to take the following actions: 1. Place a copy of this notification with each unit of affected product currently in your inventory. Users should note This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions. 2. After step (1) is complete, fill out the enclosed Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. Upon finding additional lots, the firm issued additional letter on 06/27/2018 with the same message as the letter disseminated in March.

Device

Device Recall Simplastic Suprapubic Puncture Instrument
  • Model / Serial
    Product Code Equivalent Code (a) 650704100 551310 Batch Numbers: 13HE35 14KE45  (b) 650704120 551312 Batch Numbers: 13EE20 13HE35 13JE43 14AE02 14BE07 14EE21 14GE29 14IE39 15AE03 15HE32  (c) 650704160 551316 Batch Numbers: 13GE31 13HE35 13JE41 13JE42 13JE43 13KE48 14AE03 14BE07 14CE11 14DE17 14DE18 14EE21 14EG21 14GE28 14HE33 14HE35 14IE39 14KE45 15AE03 15EE20 15EE22 15GE28 15JE43 15JE44 13EG28 13HG23
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    Simplastic Suprapubic Puncture Instruments: || Product Code Equivalent Code || (a) 650704100 551310 || (b) 650704120 551312 || (c) 650704160 551316 || Product Usage: || RUSCH Simplastic Suprapubic Puncture Instruments are indicated for emergency suprapubic drainage of the bladder.
  • Manufacturer
    Teleflex Medical Europe Ltd

Manufacturer

Teleflex Medical Europe Ltd
  • Manufacturer Address
    Teleflex Medical Europe Ltd, Ida Business Park, Athlone Ireland
  • Manufacturer Parent Company (2017)
    Teleflex Incorporated
  • Source
    USFDA