Z-1129-2023 Class II Ongoing
FDA device recall Z-1129-2023 was initiated by Access Vascular, Inc on December 16, 2022 and is designated Class II. Reason for recall: 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. The recall status is ongoing. Affected quantity: 1,789 HydroMID devices.
Recall Details
- Product Type
- Devices
- Report Date
- February 22, 2023
- Initiation Date
- December 16, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,789 HydroMID devices
Product Description
HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution in the states of CT, IL, IN, MA, NE, TN, and TX.
Code Information
UDI-DI: (01)00850030354006; Lot Number: 11428361, 11393260, 11395226