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Open, Classified

BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Female REF: RTU14F

FDA Recall Z-1061-2026 · Posted 2026-01-12

Recall StatusOpen, Classified
Product CodeGBM
Date Initiated2025-11-29
Product Quantity149310 units

Reason for Recall

Labeling error, Incorrect expiration date

Firm Action

On November 29, 2025, Hangzhou Bever Medical Devices issued a "Medical Device Recall" Notification via E-Mail. Hangzhou asked consignees to take the following actions: 1) Immediately discontinue the distribution of the RTU14F product (Lot Number T21823), and isolate the products of this lot in inventory to avoid incorrect shipment or use. 2) Discard the affected devices in compliance with local, state, and federal medical waste regulations. 3.If no alternative products are available currently, you may contact your sales representative to inquire about temporary alternative devices or solutions. 4) After receiving this letter, please fill in the attached Recall Return Response Form, and return to us via email to confirm receipt of the recall notice. 5) Forward the Customer Notification Letter and the Recall Return Response Form and to downstream customers, 6) Handle all replacement requests from your downstream customers and coordinate the delivery of replacement units to your downstream customers once received from Bever.

Root Cause

Labeling Change Control

Distribution Pattern

US Nationwide distribution in the state of GA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

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

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