Medline Industries, LP: Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116I

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.

Details from the source

Reason for recall: 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. Distribution: US Nationwide distribution in the states of CA, FL, MD. PA, and TX. Quantity: 980 kits Lot/code info: DYKMBNDL116I UDI-DI 10198459644764 Lots 26ABL226 26BBD710

UPC codes

10198459644764

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.