Agency classClass IIOur severity:High FDA (Devices)·Z-1343-2025·Announced 2025-03-26

PICC Line Catheters Recalled for Sterilization Assurance Issues

American Contract Systems is recalling PICC line catheters because sterilization assurance requirements could not be confirmed. Unsterilized devices may lose functionality and delay patient treatment.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: No reported illnesses or injuries exist. This is a Class II recall where sterilization assurance cannot be confirmed. Although central line catheters are high-risk implantable devices where contamination poses serious infection risk, the absence of reported harm and Class II classification result in a High (3) severity score per FDA rubric.

Plain-English summary

American Contract Systems Inc is recalling CENTRAL LINE PICC catheters, Models LLCL44H and LLCL44H-01, due to sterilization assurance failures. The manufacturer is unable to confirm that required sterilization procedures were completed or that sterilization standards were met. PICC lines are peripherally inserted central catheters used to deliver medication and fluids directly into the bloodstream.

A total of 1,420 units were distributed in Ohio. The recalled devices carry lot numbers 70-050707, 70-050860, 70-051149, 70-051713, 70-052363, and 70-053044. Health care facilities and clinics that received these devices should discontinue use immediately.

If a recalled PICC line was inserted into a patient, the patient's healthcare provider should evaluate whether the device should be removed and replaced. Unsterilized medical devices carry a risk of serious infection. Patients who believe they received a recalled PICC line should contact their healthcare provider immediately.

The recalled product

Product: CENTRAL LINE PICC , Model No LLCL44H LLCL44H-01
Manufacturer: American Contract Systems Inc
Category: Medical Device — Central Line / Vascular Access
Hazard: sterilization-failure
infection-risk
device-malfunction
Affected units: 1,420

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 32 recalled by American Contract Systems Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 32 products in this recall →

Same manufacturer · American Contract Systems Inc

See all →

Severe
FDA Recalls Medical Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
High
FDA Recalls Medical Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
High
Recall of Medical Convenience Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
Moderate
American Contract System Convenience Kits Recalled for Performance Failures
FDA (Devices) · 2026-09-02
Moderate
American Contract Systems Recalls Convenience Kits with Non-Conforming Catheters
FDA (Devices) · 2026-09-02

Same hazard · sterilization failure