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.
FDA Recall Z-2055-2019 · Posted 2019-07-23
Advertisement
Recalling FirmInfuTronix LLC
Recall StatusTerminated
Product CodeFRN
Date Initiated2019-05-28
Date Terminated2020-06-22
Product Quantity10,800 units
Reason for Recall
Potential for tube leakage
Firm Action
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 [email protected].
Root Cause
Employee error
Distribution Pattern
US distribution in the state of MA
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement