Device product
EQUISTREAM¿ XK Long-Term Hemodialysis Catheter. REF/UDI:5913230/:(01)00801741013843; 16F
Z-2208-2020
Product summary
- Event
- Event 85510
- Status
- Terminated
- Classification
- Class II
- Quantity
- 215
- Official record key
device-enforcement:Z-2208-2020
Official wording
Reason: Incorrect Peel-Apart Introducer Sheath in Kit.
Code information: LOT RECV3572
Distribution pattern: 67 US Consignees. US - AL, AR, AZ, CA, FL, GA, IA, ID, IL, KY, LA, MD, MN, MT, NC, NY, OR, PA, TN, TX, VA, WA, WI and WV.
Derived failure modes
-
Unknown
Incorrect Peel-Apart Introducer Sheath in Kit.