HANGZHOU BEVER MEDICAL DEVICES CO., LTD. recalls BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip
Reason for recall
Labeling error, Incorrect expiration date
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Female REF:RTU14FAffected lotT21823
What the firm is doing
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.
DistributionShow detailsHide
US Nationwide distribution in the state of GA.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1061-2026
- FDA 510(k) clearance · K192468The device's official FDA premarket clearance record
- FDA device classification · GBMOfficial FDA classification for this device type
- CFR regulation · 21 CFR 876.5130The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find HANGZHOU BEVER MEDICAL DEVICES CO., LTD.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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