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Moderate riskFDA DeviceClass II

Medline urology robotic procedure packs recalled for defective Bard Silastic Foley Catheters

Medline convenience kits used in urology robotic procedures contain Bard Silastic Foley Catheters with excess raw material on the catheter surface. This material may cause staining and could potentially harm patients. The catheters were originally recalled by the manufacturer due to this manufacturing defect.

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

What to do

  1. If you received affected kits (lot numbers 25IMC004, 25JMD942, 25JMJ441, or 25LMG068), do not use them.
  2. Contact Medline Industries or your facility's medical device coordinator for instructions on returning or replacing the kits.
  3. Check your facility's inventory of urology robotic procedure packs, especially if located in CA, FL, MD, PA, or TX.
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. UROLOGY ROBOTIC PROCEDURE PACK DYNJ0945779U
Sold in
Nationwide
Made for
Adults (18 years to 100 years)

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-2781-2026

In the FDA's words

Description
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. UROLOGY ROBOTIC PROCEDURE PACK DYNJ0945779U 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. DYNJ0945779U UDI-DI 10195327632656 Lots 25IMC004 25JMD942 25JMJ441 25LMG068 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.

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