FDA Enforcement
Class II
Ongoing
HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80002002
Recall: Z-0114-2024
·
Reported October 25, 2023
Enforcement
- Recall Number
- Z-0114-2024
- Event ID
- 93043
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Access Vascular, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 25, 2023
- Initiation Date
- August 31, 2023
- Classification Date
- October 13, 2023
- Address
- 749 Middlesex Tpke, N/A, Billerica, MA, 01821-3906, United States
Description
HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80002002
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 Info
UDI-DI: 00850030354044; Lot Number: 11423187
Distribution
US Nationwide distribution in the states of IL, TX.
Quantity
58 total