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.
- Company
- Infutronix Llc
- Recall Initiated
- May 28, 2019
- Posted
- July 23, 2019
- Terminated
- June 22, 2020
- Recall Number
- Z-2055-2019
- Quantity
- 10,800 units
- Firm Location
- Natick, MA
Reason for Recall
Potential for tube leakage
Distribution
US distribution in the state of MA
Lot / Code Info
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
Root Cause
Employee error
Action Taken
On May 28, 2019 InfuTronix LLC issued Voluntary Recall notices to their customer via email. On June 10, 2019, InfuTronix LLC issued a second notice to customers via email dated June 4, 2019 which provides more information on the reason for recall. On August 6th, 2019, InfuTronix LLC issued a third Urgent Medical Device Recall notice to customers advising them of an additional lot. Customers are advised to take the following actions: 1) Inspect stock and remove all products listd on the notice. 2) Immediately return them to InfuTronix LLC for replacement. 3) Customers may call the telephone number listed or email for instructions on what to do with the product. 4) Please contact InfuTronix at 508-907-7791 Monday to Friday 9:30 am to 5 pm, EST. 5) Return the completed response form via email to Peter.Nikki@infutronix.com.