Device product
HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80002002
Z-0114-2024
Product summary
- Event
- Event 93043
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 58 total
- Official record key
device-enforcement:Z-0114-2024
Official wording
Reason: 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 warnings statement: HydroPICC Dual Lumen Catheter is for adult use only. There is a potential risk to health should the HydroPICC Dual Lumen Catheter be used in an inadequately sized vessel. There have been no reported adverse events to date.
Code information: UDI-DI: 00850030354044; Lot Number: 11423187
Distribution pattern: US Nationwide distribution in the states of IL, TX.
Derived failure modes
-
Unknown
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 warnings statement: HydroPICC Dual Lumen Catheter is for adult use only. There is a potential risk to health should the HydroPICC Dual Lumen Catheter be used in an inadequately sized vessel. There have been no reported adverse events to date.