—#171318

Product

Teleflex MEDICAL RuSCH One piece Male External Regular Catheter W/O Tape, REF A1500

FDA product code: NNY — Sheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-Sterile
Device class: Class 1
Medical specialty: Gastroenterology, Urology
Affected lot / code info: GTIN 24026704549836 Lot Numbers: 74A1800914, 74A1801938, 74A1802088, 74B1800292, 74B1800362, 74B1801603, 74C1800428, 74C1801090, 74C1801172, 74C1802127, 74E1800684, 74E1802780, 74F1800358, 74F1801409, 74F1801915, 74G1800046, 74G1800893, 74G1801165, 74H1700889, 74H1701630, 74H1702627, 74J1701765, 74J1702485, 74K1700319, 74L1700073, 74L1700304

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Teleflex Medical
Address: 3015 Carrington Mill Blvd, Morrisville, North Carolina 27560-5437

Distribution

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

Timeline

Recall initiated: 2019-02-27
Terminated: 2023-09-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #171318. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.