InfuTronix LLC 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
InfuTronix LLC
Lot Codes / Batch Numbers
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
Products Sold
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
InfuTronix LLC is recalling Nimbus Administration Set, REF HS-004, UDI # 00817170020031 Product Usage: Administer fluids/med due to Potential for tube leakage. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for tube leakage
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN, MA
Page updated: Jan 10, 2026