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Terminated

Teleflex MEDICAL RuSCH One piece Male External Medium Catheter W/O Tape, REF A1500M

FDA Recall Z-0797-2020 · Posted None

Recalling FirmTeleflex Medical
Recall StatusTerminated
Product CodeNNY
Date Initiated2019-02-27
Date Terminated2023-09-06
Product Quantity13104 devices

Reason for Recall

The device label incorrectly states that the device is sterile. This product is an externally applied male condom-type catheter designed for the management of male incontinence as an alternative to incontinence pads. In normal use, the device is neither expected nor required to be sterile.

Firm Action

The firm initiated the recall by letter on 02/27/2019. The notice stated that the device label incorrectly identified the products as sterile. Although incorrectly labeled as sterile, there is no requirement for sterility for its use. The firm requested that the distributors notify their customers. The firm did not request the return of the units, only to attach the notice to any recalled product in stock.

Root Cause

Under Investigation by firm

Distribution Pattern

ME,NC, WA, MO, NJ, FL, CAL, TX, OH, IL, MA, GA, FL, GA, Canada

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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