| 2023-08-31 |
Class II
|
Ongoing |
Z-0115-2024 |
HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004 |
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Specific lots of the Dual Lumen HydroPICC Kits were provided with the incorrect revision of the Instructions For Use (IFU) which do not include the following wa… |
| 2023-08-31 |
Class II
|
Ongoing |
Z-0114-2024 |
HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80002002 |
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Specific lots of the Dual Lumen HydroPICC Kits were provided with the incorrect revision of the Instructions For Use (IFU) which do not include the following wa… |
| 2023-03-03 |
Class II
|
Ongoing |
Z-1605-2023 |
HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004 |
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The catheter packaged with specific lots of the HydroPICC Kits and HydroMID Kits have a shorter expiration date than what is listed on the outer kit package. |
| 2022-12-22 |
Class II
|
Ongoing |
Z-1156-2023 |
HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term access (<30days) to the peripheral venous acces… |
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Label with the incorrect component listed on the inner kit Tyvek header bag |
| 2022-12-22 |
Class II
|
Ongoing |
Z-1155-2023 |
HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term access (<30days) to the peripheral venous acce… |
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Product Mislabeled on the outer bag and inner kit Tyvek header bag |
| 2022-12-16 |
Class II
|
Ongoing |
Z-1131-2023 |
HydroPICC 4Fr Single Lumen, 130cm Guidewire - Basic Kit, Model Number 80001001 |
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Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters expire prior to the labeled expiration date of the kit. |
| 2022-12-16 |
Class II
|
Ongoing |
Z-1130-2023 |
HydroPICC 4Fr Single Lumen, 80cm Guidewire - Basic Kit, Model Number 80001002 |
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Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters expire prior to the labeled expiration date of the kit. |
| 2022-12-16 |
Class II
|
Ongoing |
Z-1129-2023 |
HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002 |
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Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters expire prior to the labeled expiration date of the kit. |
| 2021-02-24 |
Class II
|
Terminated |
Z-0199-2023 |
Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally Inserted Central Catheter |
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Scalpel and StatLock components packaged with specific lots of the HydroPICC catheter have a shorter expiration date than what is listed on the outer kit packag… |