The Recall Desk
HighFDA (Devices)·Z-0162-2025·Announced 2024-10-30

Medline Central Catheter Insertion Kit Recalled for Potential Non-Sterile Packaging

Medline CENTRAL CATHETER INSERTION KIT (Ref CVI680C) is being recalled because certain units may be non-sterile due to potential seal failures in packaging. The recall affects 1,180 units distributed in the US, Canada, and Panama.

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: FDA Class II recall of an invasive medical device (central catheter kit) with inherent risk of serious infection if non-sterile. No illnesses or injuries have been reported. Meets rubric criterion for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Medline Industries has recalled CENTRAL CATHETER INSERTION TRA (Ref CVI680C), a sterile medical procedure kit used for central catheter insertion. The recall involves 1,180 units worldwide.

The recall was issued because convenience kits packaged in breather pouches with lot number 323080002 may result in non-sterile product if the vendor seal of the pouch is opened or unsealed. When a pouch seal is compromised, the product inside may no longer maintain its required sterility, creating a risk that medical personnel could unknowingly use non-sterile equipment during a sterile invasive procedure.

The affected units have been distributed worldwide, including the United States, Canada, and Panama. Affected product lot number is 23LBO846.

Healthcare facilities and clinicians using this product should verify that their inventory does not include the affected lot numbers and discontinue use of any identified units. Users should contact Medline Industries or the FDA for instructions on safe disposition of recalled product.

The recalled product

Product
Medline CENTRAL CATHETER INSERTION TRA, REF CVI680C; medical procedure convenience kit
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Central Catheter Kit
Hazard
  • non-sterile-product
  • infection-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • UDI/DI 40653160992944 (each)
  • 10653160992943 (case)
  • Lot Numbers: 23LBO846

Distribution

Distributed nationwide across the United States.

Related recalls

Same category