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Terminated

MED-RX POLYURETHANE FEEDING TUBE For Pediatric Use with Orange Radioplaque Stripe and Enteral Connector, 6.5Fr X 24" (60cm), REF 54-2465-R Product Usage: A Nasogastric/Oralgastric enteral feeding tube. The MED-RX Feeding Tube is intended to be used for nasogastric/oralgastric enteral feeding as directed by a physician.

FDA Recall Z-0725-2019 · Posted None

Recall StatusTerminated
Product CodeFPD
Date Initiated2018-12-01
Date Terminated2021-04-02
Product Quantity75 cases of 10

Reason for Recall

The product may be packaged with a 5FR X 24 length Feeding tube instead of a 6.5 FR X 24 Feeding tube as labeled.

Firm Action

The firm notified its consignees of the recall by email on 12/01/2018. The letter identified the affected product, problem and actions to be taken. The firm requested return of the product.

Root Cause

Under Investigation by firm

Distribution Pattern

US in the states of 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.

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