FDA-Device2026-07-29Class IIPROCESSING DEFECT

Medline DaVinci Prostate Pack kits recalled for defective Bard Foley Catheters

OTHERNationwide distribution

Medline DaVinci Prostate Pack recalled for defective catheters

Medline convenience kits containing Bard Silastic Foley Catheters have been recalled because the catheters have an increased amount of raw material on their surface. This material may cause staining and could be harmful if the catheters are used.

  • Stop using affected DaVinci Prostate Pack kits (model DYNJ68477L or DYNJ68477M) if you have them.
  • Check the lot number on your kit: 25HMF458, 25LME235, 26CMK219, or 26EMG622.
  • Contact your supplier or Medline for instructions on how to return or dispose of the kits.
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.

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. DAVINCI PROSTATE PACK DYNJ68477L DYNJ68477M

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2780-2026

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