Device product
AVID TruCustom CATH PACK convenience kits, Item Code: LGHM036-14
Z-0786-2018
Product summary
- Event
- Event 79162
- Status
- Terminated
- Classification
- Class II
- Quantity
- 444
- Official record key
device-enforcement:Z-0786-2018
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: 1190449, 2/1/2019; 1210124, 6/1/2019; 1217082, 8/1/2019; 1219275, 3/1/2019; 1221265, 3/31/2019; 1222551, 7/1/2019
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