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.
What this means for you
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
- Hazard
- sterilization-failure
- infection-risk
- device-malfunction
Distribution
Distributed nationwide across the United States.
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