Device product
Nimbus Administration Set, REF HS-004, UDI # 00817170020031 Product Usage: Administer fluids/medication from a container to a patient through a needle or a catheter.
Z-2055-2019
Product summary
- Firm
- InfuTronix LLC
- Event
- Event 82997
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10,800 units
- Official record key
device-enforcement:Z-2055-2019
Official wording
Reason: Potential for tube leakage
Code information: 1) Lot # 1805002, Exp Date 06/10/2021, 2) Lot # 1712005, Exp Date 12/19/2020, 3) Lot # 1710012, Exp Date 10/22/2020, 4) Lot # 1901003, Exp Date 01/07/2022
Distribution pattern: US distribution in the state of MA
Derived failure modes
-
Unknown
Potential for tube leakage