Nimbus Administration Set, REF HS-004, UDI # 00817170020031 Product Usage: Administer fluids/medication from a container
FDA device recall Z-2055-2019 · posted 2019-07-23 · Terminated
Recall details
- Recalling firm
- InfuTronix LLC
- Reason for recall
- Potential for tube leakage
- 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.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 10,800 units
- Distribution
- US distribution in the state of MA
- Date initiated
- 2019-05-28
- Date posted
- 2019-07-23
- Date terminated
- 2020-06-22
- Location
- Natick, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System) (K153193) | Zyno Medical, LLC | 2016-08-30 |
| SALVATION 3DI PLATING SYSTEM (K140792) | Wrightmedicaltechnologyinc | 2014-05-22 |