Z-0790-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 7, 2018
- Initiation Date
- June 22, 2017
- Termination Date
- October 12, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 160
Product Description
AVID TruCustom GYN LAPAROSCOPY convenience kits, Item Code: LGHM013-06 and LGHM013-07
Reason for Recall
Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.
Distribution Pattern
Distributed in 10 states: IL, KY, LA, MA, MO, NY, OH, TX, VA, WI.
Code Information
Lot, Expiration Date: 1191787, 7/1/2018; 1216674, 9/1/2019