Z-1605-2023 Class II Ongoing
FDA device recall Z-1605-2023 was initiated by Access Vascular, Inc on March 3, 2023 and is designated Class II. Reason for recall: 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. The recall status is ongoing. Affected quantity: 240 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 24, 2023
- Initiation Date
- March 3, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 240 units
Product Description
HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004
Reason for Recall
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.
Distribution Pattern
US distribution to States of: FL, TN, TX.
Code Information
UDI-DI: 00862559000487; Lot Number: 11423949