Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

MED-RX POLYURETHANE FEEDING TUBES: a) 5Fr X 16" (40cm), REF 54-1650R b) 6.5Fr X16" (40cm), REF 54-1665R c) 5Fr X 24" (60cm), REF 54-2450R d) 6.5Fr X 24" (60cm), REF 54-2465R e) 8Fr X 24: (60cm), REF 54-2480R f) 8Fr X 36" (91cm), REF 54-3680R

FDA Recall Z-2281-2019 · Posted None

Recall StatusTerminated
Product CodeFPD
Date Initiated2019-07-16
Date Terminated2025-05-28
Product Quantity2870 units

Reason for Recall

The firm received a complaint that the connector detached from the feeding tube.

Firm Action

The firm initiated the recall by email on 07/16/2019. The notice requested the consignee cease distribution/use of the product, complete and return the product recall response form to arrange for product return and replacement/credit.

Root Cause

Under Investigation by firm

Distribution Pattern

GA and TN

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.

↑