Device product
Outlook Safety Infusion System Y-type Blood Set, Catalog Number 477005
Z-0935-2020
Product summary
- Event
- Event 84365
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,824 units
- Official record key
device-enforcement:Z-0935-2020
Official wording
Reason: Potential for leakage at the joint between the blood filters and tubing
Code information: GUIDID: 04046955202799 Lot Numbers: 61679395 - Expiration Date: May 31, 2022, 61685454 - Expiration Date: June 30, 2022
Distribution pattern: US Nationwide
Derived failure modes
-
Unknown
Potential for leakage at the joint between the blood filters and tubing