Recall Z-0199-2023— Access Vascular, Inc.

Name: FDA recall Z-0199-2023
Creator: U.S. Food and Drug Administration
Published: 2021-02-24

Class II · Terminated

Class II FDA medical device recall by Access Vascular, Inc., initiated 2021-02-24, terminated 2024-05-30. It names one FDA 510(k) clearance: K193015. Product: Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally Inserted Central Catheter. Reason: Scalpel and StatLock components packaged with specific lots of the HydroPICC catheter have a shorter expiration date than what is listed on the outer kit package..

Recalling firm: Access Vascular, Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-02-24
Terminated: 2024-05-30
Firm location: Billerica, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K193015 — HydroPICC (PICC-142)Access Vascular, Inc.·cleared 2020-02-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally Inserted Central Catheter

Reason for recall

Scalpel and StatLock components packaged with specific lots of the HydroPICC catheter have a shorter expiration date than what is listed on the outer kit package.

Data sourced from openFDA. This site is unofficial and independent of the FDA.