FDA Medical Device Recalls (openFDA)
Fresenius Kabi USA, LLC: LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032-25.
- Recall number
- Z-2235-2025
- Recalling firm
- Fresenius Kabi USA, LLC
- Product
- LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032-25.
- Status
- Open, Classified
- Initiated
- 2025-06-24
- Posted
- 2025-08-01
- Terminated
- not on file
- Reason
- Potential for external cassette leaks
- Root cause
- Process design
- Action
- Fresenius Kabi notified consignees on about 06/24/2025 via telephone call and followed up with a letter. Consignees were instructed to discontinue use and distribution immediately, quarantine any affected units on hand, notify users of the issue, and complete and return the Customer Reply Form. If affected units were further distributed, consignees were instructed to notify those customers. If Affected units were on hand, consignees were instructed to either destroy or arrange for their return. Replacement of affected units can be arranged.
- Quantity
- 348,150 units
- Distribution
- US Nationwide distribution in the states of CA, CO, DE, FL, GA, ID, IL, MA, MD, MI, MN, MS, NJ, NV, OK, OR, SC, TX, VA, WA, WI.
- Lot, serial or model codes
- Product Code: SET-0032-25. UDI-DI: 00811505030214. Lot Codes: FA24J03137, FA24J03145, FA24J07013, FA24J07021, FA24J14019, FA24J14027, FA24J21246, FA24J21253, FA24J24141, FA24J24166, FA24J28027, FA24J28035, FA24K01154, FA24K01162, FA24K11039, FA24K11047, FA24K11161, FA24K18034, FA24K18042, FA24K18059, FA24K25229, FA24L03133, FA24L09221, FA24L10203, FA24L11201, FA24L11219, FA24L16010, FA24L16028, FA24L16036, FA24L18180, FA24L19139, FA24L19147.
- 510(k) numbers
- ["K183311"]
- PMA numbers
- not on file
- Product code
- FRN
- Firm FEI
- 3014732157
- Firm city
- North Andover
- 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