FDA Medical Device Recalls (openFDA)
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 number
- Z-2055-2019
- Recalling firm
- InfuTronix LLC
- 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.
- Status
- Terminated
- Initiated
- 2019-05-28
- Posted
- 2019-07-23
- Terminated
- 2020-06-22
- Reason
- Potential for tube leakage
- Root cause
- Employee error
- 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 Peter.Nikki@infutronix.com.
- Quantity
- 10,800 units
- Distribution
- US distribution in the state of MA
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K140792","K153193"]
- PMA numbers
- not on file
- Product code
- FRN
- Firm FEI
- 3011581906
- Firm city
- Natick
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28