FDA-Device2026-07-29Class IIPROCESSING DEFECT

Medline convenience kits with Bard Silastic Foley Catheters recalled for surface contamination

OTHERNationwide distributionMedical devices

What this means

Medline convenience kits containing Bard Silastic Foley Catheters (sizes 16, 18, and 20 French, 5cc balloons) include catheters with excess raw material on the surface. This material may cause staining and could be harmful if the catheters are used.

  • Check if you have affected Medline convenience kits with Bard Silastic Foley Catheters in sizes 16, 18, or 20 French.
  • Do not use catheters from lots 25KBJ177, 25LBO527, or 26ABT761.
  • Contact your healthcare provider or Medline for instructions on replacement or disposal.
The agency's original wording
Hazard

Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.

Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of CA, FL, MD. PA, and TX.
Affected count
980 kits
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. ROBOTIC CDS980523M

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2784-2026

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