Device product
AVID TruCustom ELECTRO PHYSIOLOGY PK convenience kits, Item Code: LGHM033-04
Z-0787-2018
Product summary
- Event
- Event 79162
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15
- Official record key
device-enforcement:Z-0787-2018
Official wording
Reason: 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.
Code information: Lot, Expiration Date: 1150308 ,1/1/2020
Distribution pattern: Distributed in 10 states: IL, KY, LA, MA, MO, NY, OH, TX, VA, WI.
Derived failure modes
-
Foreign material or chemical contamination
foreign material