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

Is my product affected?

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

• UPC 24026704549843

Check against the official notice below — it lists the full affected range.

What happened

Teleflex Medical is recalling approximately 13,104 Rüsch One Piece Male External Medium Catheters without tape because the device label incorrectly states that the product is sterile. This externally applied male condom-type catheter is designed to manage male incontinence as an alternative to incontinence pads and does not need to be sterile for normal use. The affected devices were distributed in multiple states including California, Texas, Florida, Illinois, Ohio, Massachusetts, Georgia, North Carolina, Washington, Missouri, New Jersey, and Maine, as well as Canada.

The recalled product has the GTIN 24026704549843 and includes 13 lot numbers ranging from 74A1800577 through 74M1701769. The source document does not specify what action affected consumers should take regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

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. Distribution: ME,NC, WA, MO, NJ, FL, CAL, TX, OH, IL, MA, GA, FL, GA, Canada Quantity: 13104 devices Lot/code info: GTIN 24026704549843 Lot Numbers: 74A1800577, 74G1802121, 74A1801939, 74H1700894, 74B1800363, 74J1700864, 74B1801604, 74J1702489, 74B1802746, 74C1801178, 74K1702257, 74L1700074, 74C1801294 , 74L1701701, 74C1802132, 74M1700121, 74G1800047, 74M1701150, 74G1800891, 74M1701769, 74G1801166

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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