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
- Recall Number
- Z-2055-2019
- Event Number
- 82997
- Firm
- InfuTronix LLC
- FEI Number
- 3011581906
- Product Code
- FRN
- Status
- Terminated
- Root Cause
- Employee error
- Initiated
- May 28, 2019
- Posted
- July 23, 2019
- Terminated
- June 22, 2020
- Address
- 177 Pine St, Natick, MA, 01760-1331
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.
Potential for tube leakage
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].
US distribution in the state of MA
10,800 units