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RUSCH

TELEFLEX INCORPORATED · Model IPN053439 · UDI-DI 04026704549566

NNY Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

Contents: RUSCH Golden-Drain® Catheter Small Size Catheter Single Sided Adhesive

Recalls

Date	Firm	Reason
2019-02-27	Teleflex Medical	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
2019-02-27	Teleflex Medical	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
2011-06-27	Teleflex Medical	The Kit contains Skin-Prep protective wipes that were manufactured by the Triad Group and are being recalled by Smith & Nephew, due to possible bacterial contamination.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.