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Open, Classified

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.

FDA Recall Z-1051-2026 · Posted 2026-01-12

Recalling FirmMedline Industries, LP
Recall StatusOpen, Classified
Product CodeOFF
Date Initiated2025-11-26
Product Quantity32 units

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.

Firm 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 [email protected].

Root Cause

Nonconforming Material/Component

Distribution Pattern

US Nationwide distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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