Z-1887-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 23, 2018
- Initiation Date
- March 26, 2018
- Termination Date
- April 8, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1500
Product Description
5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 150mm shaft length, 2B5XT
Reason for Recall
Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. In addition, insufficient lubrication could result in a remote chance of introducing a minute particle if repeated insertions of the obturator or laparoscopic device damage the seal.
Distribution Pattern
Nationwide domestic distribution, including PR. International distribution to Saudi Arabia, United Arab Emirates, Belgium, Singapore, Taiwan, South Korea, Canada, Chile, Mexico, Japan, and Argentina.
Code Information
Lots P4TD1E R4001U R4052P