FDA Medical Device Recalls (openFDA)
HANGZHOU BEVER MEDICAL DEVICES CO., LTD.: BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Female REF: RTU14F
- Recall number
- Z-1061-2026
- Recalling firm
- HANGZHOU BEVER MEDICAL DEVICES CO., LTD.
- Product
- BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Female REF: RTU14F
- Status
- Open, Classified
- Initiated
- 2025-11-29
- Posted
- 2026-01-12
- Terminated
- not on file
- Reason
- Labeling error, Incorrect expiration date
- Root cause
- Labeling Change Control
- 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.
- Quantity
- 149310 units
- Distribution
- US Nationwide distribution in the state of GA.
- Lot, serial or model codes
- UDI: (01)06948796204063/Lot # T21823
- 510(k) numbers
- ["K192468"]
- PMA numbers
- not on file
- Product code
- GBM
- Firm FEI
- 3008729910
- Firm city
- Hangzhou
- Firm state
- not on file
- Firm country
- China
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