Z-0114-2024 Class II Ongoing
FDA device recall Z-0114-2024 was initiated by Access Vascular, Inc on August 31, 2023 and is designated Class II. Reason for recall: 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 C… The recall status is ongoing. Affected quantity: 58 total.
Recall Details
- Product Type
- Devices
- Report Date
- October 25, 2023
- Initiation Date
- August 31, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 58 total
Product Description
HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80002002
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution in the states of IL, TX.
Code Information
UDI-DI: 00850030354044; Lot Number: 11423187