FDA Medical Device Recalls (openFDA)
Medline Industries, LP: Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: RR-LAP DONOR NEP ACCESSORY, Medline kit SKU DYNJ63395B
- Recall number
- Z-1053-2026
- Recalling firm
- Medline Industries, LP
- Product
- Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: RR-LAP DONOR NEP ACCESSORY, Medline kit SKU DYNJ63395B
- Status
- Open, Classified
- Initiated
- 2025-11-26
- Posted
- 2026-01-12
- Terminated
- not on file
- Reason
- Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
- Root cause
- Nonconforming Material/Component
- Action
- Medline issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 11/26/2025 via email and USPS first class mail. The notice explained the issue potential risk to the patient, and referred the consignee to the attached B Braun notice for further instructions. The B Braun notice provide "Interim Measures for Users" to provide for the continued use of the product. For questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
- Quantity
- 33 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- UDI/DI 10195327634698 (EA) 40195327634699 (CS), Lot numbers: 25HLA435, 25HLB046.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- RDE
- Firm FEI
- 1417592
- Firm city
- Northfield
- Firm state
- IL
- 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