Device product
Arterial Access Tray, introducer catheter; Model: GU-04020
Z-1287-2018
Product summary
- Event
- Event 79314
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1190
- Official record key
device-enforcement:Z-1287-2018
Official wording
Reason: The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.
Code information: Lots: 13F17A0292, 13F17C0309, 13F17E0359, 13F17G0300, 13F17J0242, 23F16F0623, 23F16G0675; Expiration dates: October 2018 through March 2020
Distribution pattern: US nationwide distribution, including Puerto Rico.
Derived failure modes
-
Unknown
The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.