| 2026-03-18 |
Class II
|
Ongoing |
Z-1941-2026 |
Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm, REF 1205-20 |
— |
The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each st… |
| 2026-03-18 |
Class II
|
Ongoing |
Z-1940-2026 |
Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 15mm-16.5mm-18mm, REF 1205-18 |
— |
The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each st… |
| 2026-03-18 |
Class II
|
Ongoing |
Z-1939-2026 |
Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 12mm-13.5mm-15mm, REF 1205-15 |
— |
The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each st… |
| 2026-03-18 |
Class II
|
Ongoing |
Z-1938-2026 |
Diversatek Healthcare Viper¿ 3-Stage Fixed Wire Balloon Dilator, 6mm-7mm-8mm, REF 1204-08 |
— |
The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each st… |
| 2025-06-04 |
Class III
|
Ongoing |
Z-2324-2025 |
Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10 |
— |
Anorectal manometry procedure kit outer kit label is mislabeled with an incorrect expiration date; the manufacturing date was used in place of the expiration da… |
| 2023-07-25 |
Class III
|
Ongoing |
Z-2521-2023 |
ZVU Functional GI Software, REF: ZVU-3 |
— |
GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0. |
| 2021-10-29 |
Class II
|
Terminated |
Z-1771-2022 |
Diversatek Health, M-Catch Retrieval Nets, Part Number REF 1175-01, Quantity 5 EA/u. Used to endoscopically retrieve s… |
— |
M-Catch Retrieval Nets, Part Number 1175-01 / Lot Number 001919, that were shipped between 9-27-2021 and 10-22-2021, may contain incorrect inner polybag labelin… |