Device product
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ENSEMBLE GYNECO SCOPIE-LF DYNJ53744B LAVH GRH-LF DYNJ41792G
Z-1892-2026
Product summary
- Event
- Event 98601
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 270,311 total
- Official record key
device-enforcement:Z-1892-2026
Official wording
Reason: Unapproved design changes to the products outside of the 510(k) clearance.
Code information: DYNJ53744B UDI-DI 10193489761689 (EA) 40193489761680 (CS) LOT 24ABS765 DYNJ41792G UDI-DI 10195327547127 (EA) 40195327547128 (CS) LOT 24ABT556
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.
Derived failure modes
-
Device software or design
Unapproved design changes