Device product
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes E P DRAPE PACK-LF DYNJ0373061J
Z-1889-2026
Product summary
- Event
- Event 98601
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 270,311 total
- Official record key
device-enforcement:Z-1889-2026
Official wording
Reason: Unapproved design changes to the products outside of the 510(k) clearance.
Code information: DYNJ0373061J UDI-DI 10889942396856 (EA) 40889942396857 (CS) LOT 24ABR895
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.
Derived failure modes
-
Device software or design
Unapproved design changes