Z-2055-2019 Class II Terminated

Recalled by InfuTronix LLC — Natick, MA

Recall Details

Product Type
Devices
Report Date
July 31, 2019
Initiation Date
May 28, 2019
Termination Date
June 22, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
10,800 units

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

Distribution Pattern

US distribution in the state of MA

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