Device product
MEDLINE STERILE BASIC EYE PACK 16: 1) REF: DYNJ37743D; 2) REF: DYNJ37743F.
Z-0510-2026
Product summary
- Event
- Event 97815
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1024 units
- Official record key
device-enforcement:Z-0510-2026
Official wording
Reason: Medline has identified specific sterile eye procedure kits with pouch packaging that may exhibit open seals.
Code information: 1) REF: DYNJ37743D: UDI/DI 10193489600124 (each), 40193489600125 (case), Lot Number 25EMI333; 2) REF: DYNJ37743F: UDI/DI 10198459390685 (each), 40198459390686 (case), Lot Number 25GMD927.
Distribution pattern: US: MO
Derived failure modes
-
Sterility assurance
sterile eye procedure kits with pouch packaging that may exhibit open