FDA Medical Device Recalls (openFDA)
Medline Industries, LP: Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) DELUXE PRE OP KIT, Medline SKU DYKS2034A; 2) DELUXE PRE OP KIT, Medline SKU DYKS2006B.
- Recall number
- Z-1051-2026
- Recalling firm
- Medline Industries, LP
- Product
- Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) DELUXE PRE OP KIT, Medline SKU DYKS2034A; 2) DELUXE PRE OP KIT, Medline SKU DYKS2006B.
- 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
- 32 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- Medline kit SKU PHS972096014B UDI/DI: 10889942695911 (EA) 40889942695912 (CS), Lot Number 25IBT843; Medline kit SKU CDS984289O UDI/DI: 10198459418143 (EA) 40198459418144 (CS), Lot Number 25IMA327; Medline kit SKU DYNJ903523F UDI/DI: 10198459316593 (EA) 40198459316594 (CS), Lot Number 25IMI028.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OFF
- 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