Device product
PowerGlide ST Midline Catheter Maximal Barrier Kit-18 gauge,10 cm length Catalog Number: ST018101D
Z-1946-2020
Product summary
- Event
- Event 85287
- Status
- Terminated
- Classification
- Class II
- Quantity
- 655 kits
- Official record key
device-enforcement:Z-1946-2020
Official wording
Reason: Iincorrectly packaged without the required lidocaine as labeled
Code information: Lot Number: REDW0476 20 Exp. Date: 20OCT30 UDI: (01)00801741139390
Distribution pattern: AZ, CT, GA, IL, LA, MA, MI, MN, ND, NE, NY, OH, SD, TX),
Derived failure modes
-
Unknown
Iincorrectly packaged without the required lidocaine as labeled