Z-0797-2020 Class III Terminated
FDA device recall Z-0797-2020 was initiated by Teleflex Medical on February 27, 2019 and is designated Class III. 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 in… The recall status is terminated (terminated September 6, 2023). Affected quantity: 13104 devices.
Recall Details
- Product Type
- Devices
- Report Date
- January 22, 2020
- Initiation Date
- February 27, 2019
- Termination Date
- September 6, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13104 devices
Product Description
Teleflex MEDICAL RuSCH One piece Male External Medium Catheter W/O Tape, REF A1500M
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 Pattern
ME,NC, WA, MO, NJ, FL, CAL, TX, OH, IL, MA, GA, FL, GA, Canada
Code Information
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