Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: RR-LAP DONOR NEP ACCES
FDA device recall Z-1053-2026 · posted 2026-01-12 · Open, Classified
Recall details
- Recalling firm
- Medline Industries, LP
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- RDE
- Quantity affected
- 33 units
- Distribution
- US Nationwide distribution.
- Date initiated
- 2025-11-26
- Date posted
- 2026-01-12
- Location
- Northfield, IL
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