Recall Z-2055-2019— InfuTronix LLC
Class II · Terminated
Class II FDA medical device recall by InfuTronix LLC, initiated 2019-05-28, terminated 2020-06-22. It names 2 FDA 510(k) clearances: K153193, K140792. 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.. Reason: Potential for tube leakage.
- Recalling firm
- InfuTronix LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-05-28
- Terminated
- 2020-06-22
- Firm location
- Natick, MA, United States
510(k) clearances named in this recall
2 on FDA's record- K153193 — Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)
- K140792 — SALVATION 3DI PLATING SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Potential for tube leakage
Data sourced from openFDA. This site is unofficial and independent of the FDA.