Device product
MINI STICK MAX 4F X 10 CM STIFF .018 NI/TU NON-ECHO 2.75" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-762
Z-1342-2024
Product summary
- Event
- Event 94035
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 600 units
- Official record key
device-enforcement:Z-1342-2024
Official wording
Reason: Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case
Code information: UDI: 15051684023054 UPN: H965457621 Lot Number: Lot: 5788541 5789982 5791594 5794608 5797468 5798845
Distribution pattern: Worldwide distribution - US Nationwide and the countries of AT, CA, CH, CZ, ES, HK, KW, NL, NO, NZ, ZA.
Derived failure modes
-
Unknown
Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case