Device product
Medline Iris Scissors, Single-Use, Curved, Standard 4.5 , Model Nos. DYNJ04049 (cases), DYNJ04049H (eaches)
Z-0465-2025
Product summary
- Event
- Event 95671
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 69,611
- Official record key
device-enforcement:Z-0465-2025
Official wording
Reason: Tip protector may fall off within the packaging, resulting in compromised sterile barrier system and loss of sterility.
Code information: UDI-DI: 10080196847273 Lots 23GBV681 23HBD138 23IBF254 23LBJ787
Distribution pattern: US Nationwide distributions in the states of AL, AR, CO, CT, FL, IA, IN, KS, LA, MA, MO, NC, NY, OK, OR, RI, TN, TX, VA, WA, WY.
Derived failure modes
-
Sterility assurance
loss of sterility