Device product
Medcomp 15.SF X 24CM Titan HD CATHETER (CUFF 19CM FROM TIP) Ref: THD155024
Z-2940-2020
Product summary
- Event
- Event 86163
- Status
- Terminated
- Classification
- Class II
- Quantity
- 132 eaches
- Official record key
device-enforcement:Z-2940-2020
Official wording
Reason: Kits were packaged with the incorrect size valve peelable introducer. The kits include a 15F instead of the correct 16F valve peelable introducer
Code information: Lot # MPCT670, UDI 884908129304 Exp. Date 12/20/2020
Distribution pattern: AZ, CA. FL. GA, NC, ND, NJ, NY, OH, PA, VA, WA
Derived failure modes
-
Unknown
Kits were packaged with the incorrect size valve peelable introducer. The kits include a 15F instead of the correct 16F valve peelable introducer