FDA Device recall Z-0797-2020
Teleflex MEDICAL RuSCH One piece Male External Medium Catheter W/O Tape, REF A1500M
- FDA Device
- Class III
- terminated
- Published 2020-01-22
On 2020-01-22 the FDA classified a Class III recall of Teleflex MEDICAL RuSCH One piece Male External Medium Catheter W/O Tape, REF A1500M by Teleflex Medical, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0797-2020 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-02-27 |
| Published | 2020-01-22 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Teleflex Medical |
| Distribution | FL, GA, IL, MA, ME, MO, NC, NJ, OH, TX, WA |
Product
Teleflex MEDICAL RuSCH One piece Male External Medium Catheter W/O Tape, REF A1500M
Reason
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.
Identifiers
| code_info | GTIN 24026704549843 Lot Numbers: 74A1800577, 74G1802121, 74A1801939, 74H1700894, 74B1800363, 74J1700864, 74B1801604,…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Other recalls by Teleflex Medical
- (1) Gibeck Humid-Vent 2S Flex DC, Product #17731, sterile
FDA Device · Class II · 2022-06-01 · Teleflex Medical - (1) Teleflex Flex tube, Product #20011, sterile
FDA Device · Class II · 2022-06-01 · Teleflex Medical - Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containing components: PT-45509-S6, PT-45509-T The Arrow-Trerotola Per…
FDA Device · Class I · 2022-02-23 · Teleflex Medical - Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-WC containing components: PT-65709-C, PT-03009, PT-65…
FDA Device · Class I · 2022-02-23 · Teleflex Medical - Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-HFWC containing components: PT-65709-C, PT-03009, PT-…
FDA Device · Class I · 2022-02-23 · Teleflex Medical
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0797-2020%22
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