RUSCH recallZ-0797-2020 · Teleflex Medical · initiated Feb 27, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Teleflex Medical or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-0797-2020
- Status
- Terminated
- Initiated by the company
- Feb 27, 2019
- Recalling firm
- Teleflex Medical
- Quantity
- 13104 devices
- Product code
- NNY
- Distribution
- ME,NC, WA, MO, NJ, FL, CAL, TX, OH, IL, MA, GA, FL, GA, Canada
Product description
Teleflex MEDICAL RuSCH One piece Male External Medium Catheter W/O Tape, REF A1500M
Code information (models, lots, serial numbers)
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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- RUSCH IPN053441Teleflex Incorporated · SHEATH, CORRUGATED RUBBER, FOR NON-INDWELLING CATHETER, NON-STERILE1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 82307).
- Z-0796-2020 · TerminatedTeleflex MEDICAL RuSCH One piece Male External Regular Catheter W/O Tape, REF A1500
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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