CENTRAL LINE PICC , Model No LLCL44H LLCL44H-01

FDA Recall #Z-1343-2025 — Class II — February 6, 2025

Recall #Z-1343-2025 Date: February 6, 2025 Classification: Class II Status: Ongoing

Product Description

CENTRAL LINE PICC , Model No LLCL44H LLCL44H-01

Reason for Recall

ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.

Recalling Firm

American Contract Systems Inc — Tiffin, OH

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

1420

Distribution

US Nationwide distribution in the state of OH.

Code Information

UDI-DI 00191072219602 Lots 70-050707 70-050860 70-051149 70-051713 70-052363 70-053044

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated