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Moderate riskFDA DeviceClass II

Medline DaVinci Prostate Pack kits recalled for defective Bard Foley 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.

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

What to do

  1. Stop using affected DaVinci Prostate Pack kits (model DYNJ68477L or DYNJ68477M) if you have them.
  2. Check the lot number on your kit: 25HMF458, 25LME235, 26CMK219, or 26EMG622.
  3. Contact your supplier or Medline for instructions on how to return or dispose of the kits.
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. DAVINCI PROSTATE PACK DYNJ68477L DYNJ68477M
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-2780-2026

In the FDA's words

Description
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. DAVINCI PROSTATE PACK DYNJ68477L DYNJ68477M 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. DYNJ68477L UDI-DI 10198459487866 Lots 25HMF458 25LME235 DYNJ68477M UDI-DI 10198459678738 Lots 26CMK219 26EMG622 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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