Device product
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes FACE/RHINOPLASTY PACK DYNJ80343C PLASTIC HEAD-NECK PACK DYNJ86639
Z-1882-2026
Product summary
- Event
- Event 98601
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 270,311 total
- Official record key
device-enforcement:Z-1882-2026
Official wording
Reason: Unapproved design changes to the products outside of the 510(k) clearance.
Code information: DYNJ80343C UDI-DI 10195327507299 (EA) 40195327507290 (CS) LOT 24ABO127 DYNJ86639 UDI-DI 10195327661922 (EA) 40195327661923 (CS) LOT 24FBM972
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.
Derived failure modes
-
Device software or design
Unapproved design changes