FDA Import Refusal 853-1516808-9/210002/1 — Teleflex Medical Sdn. Bhd.

Teleflex Medical Sdn. Bhd. — FEI 3009271244

The FDA refused shipment 853-1516808-9/210002/1 from Teleflex Medical Sdn. Bhd. (Malaysia) on Dec 1, 2025. The refused product falls under Devices — CATHETER, RETENTION TYPE, BALLOON. Cited charges: 118,508 This firm has 5 or more other import refusals on record.

Refusal Details

Date
Dec 1, 2025
Country
Malaysia
Product Category
Devices
Product Code
78EZL CATHETER, RETENTION TYPE, BALLOON
Charges
118,508

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.