Z-0797-2020Class III

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

Name: Z-0797-2020 Teleflex MEDICAL RuSCH One piece Male External Medium Catheter W/O Tape, REF A1500M
Creator: Teleflex Medical
Published: 2019-02-27
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2019-02-27 / Terminated / root cause: labeling and UDI

FDA source

Teleflex Medical began a recall of Teleflex MEDICAL RuSCH One piece Male External Medium Catheter W/O Tape, REF A1500M on 2019-02-27. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0797-2020
Classification: Class III
Status: Terminated
Initiated: 2019-02-27
Posted: 2020-01-10
Terminated: 2023-09-06
Recalling firm: Teleflex Medical
Product: Teleflex MEDICAL RuSCH One piece Male External Medium Catheter W/O Tape, REF A1500M
Product code: NNY Sheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-Sterile
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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by 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.
Quantity in commerce: 13104 devices
Distribution: ME,NC, WA, MO, NJ, FL, CAL, TX, OH, IL, MA, GA, FL, GA, Canada
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0797-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0796-2020	Class III	Terminated	Voluntary: Firm initiated	2020-01-22	2020-01-10
Z-0797-2020	Class III	Terminated	Voluntary: Firm initiated	2020-01-22	2020-01-10

Product code NNY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)