Z-1889-2018 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
- 11074
Product Description
5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm, 75mm shaft length, 2CB5ST
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 P4T686 P4T79A P4T99K P4TC30 P4TD2D R40191 R40223 R4045J R4054D R40642