FDA Recall Open, Classified

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

Recall: Z-1061-2026 · Initiated November 29, 2025

Recall

Recall Number
Z-1061-2026
Event Number
98147
Firm
HANGZHOU BEVER MEDICAL DEVICES CO., LTD.
FEI Number
3008729910
Product Code
GBM
Status
Open, Classified
Root Cause
Labeling Change Control
Initiated
November 29, 2025
Posted
January 12, 2026
Address
Building 2 1-1, Houmuqiao, Yongle Village, Cangqian Street Yuhang Hangzhou China, No.

Description

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

Reason

Labeling error, Incorrect expiration date

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.

Distribution

US Nationwide distribution in the state of GA.

Quantity

149310 units