Z-1470-2013 Class II Terminated
FDA device recall Z-1470-2013 was initiated by Covidien LP on May 6, 2013 and is designated Class II. Reason for recall: Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity The recall status is terminated (terminated Aug 12, 2014). Affected quantity: 5364 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 12, 2013
- Initiation Date
- May 6, 2013
- Termination Date
- Aug 12, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5364 units
Product Description
Versaport Bladeless Optical Trocar With (2) Fixation Cannulae - 5mm Product Code: ONB5STF2C The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.
Reason for Recall
Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity
Distribution Pattern
Worldwide Distribution - USA (nationwide) and internationally to the following countries: Canada Austria Bahrain Benoni Centurion Chatsworth Czech Republic Denmark Egypt Finland France Germany Ireland Israel Italy Japan Kuwait Netherlands Norway Portugal QATAR Saudi Arabia Serbia Singapore South Africa Spain OMAN Sweden Switzerland UAE United Kingdom Venezuela
Code Information
Lot Numbers: N2J0211X through N3D0118X Note: The specific lot numbers listed below are not affected by this recall and are acceptable for use: N2H0045X,N2H0166X,N2H0286X, N2H0357X,N2 H051 6UX
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1470-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026