Recall Weekly
Moderate riskFDA DeviceClass II

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

Medline convenience kits containing Bard Silastic Foley Catheters (sizes 16, 18, and 20 French, 5cc balloons) have been recalled due to increased raw material on the catheter surface. This contamination may cause staining and could potentially be harmful if the catheters are used.

From the FDA notice · Read the official notice ↗ · All Medline recalls

What to do

  1. Stop using affected kits (lot numbers 25KBA955 or 26CBL889, UDI-DI 10195327319182).
  2. Contact Medline or your healthcare provider for replacement or guidance.
  3. Do not discard the product; return it to your supplier or Medline.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. PROSTATE ROBOTIC DYNJ901822B
Sold in
Nationwide
Made for
Adults (0 months and older)

This recall covers 9 products — see all of them.

Details

Units affected
980 kits
Illnesses reported
None reported
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Classification
Class II
Recall number
Z-2783-2026

In the FDA's words

Description
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. PROSTATE ROBOTIC DYNJ901822B 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. DYNJ901822B UDI-DI 10195327319182 Lots 25KBA955 26CBL889 Distribution: US Nationwide distribution in the states of CA, FL, MD. PA, and TX. Affected quantity: 980 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.

9 products in this recall

Medline urology kits recalled for excess catheter surface material

Medline is recalling nine urology convenience kits that contain Bard Silastic Foley catheters. The catheter maker recalled them because they have higher than intended amounts of raw material on the surface, which can cause staining and may be harmful. The kits were distributed nationwide, with confirmed distribution in California, Florida, Maryland, Pennsylvania, and Texas, and no injuries have been reported.

The agency lists each product separately. Check every one you might have.

More from Medline

See all

Related topics

OtherMedical devicesSold nationwideMore from FDA Device