Medline Bard Silastic Foley Catheter Kits Recalled Due to Surface Contamination
Medline is recalling 980 Bard Silastic Foley Catheter kits due to increased raw material on the catheter surface that may be harmful.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall for a risk-of-harm product where injury has not yet been reported. The increased raw material on the catheter surface may be harmful but no illnesses or injuries have been documented.
Plain-English summary
Medline Industries, LP is recalling 980 Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons. The kits were recalled because the catheters have an increased amount of raw material on the surface, which may result in staining and could be harmful to users. The affected kits were distributed nationwide in California, Florida, Maryland, Pennsylvania, and Texas. Consumers should stop using the affected products and contact Medline for a replacement.
The recalled product
- Product
- Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116I
- Manufacturer
- Medline Industries, LP
- Hazard
- Affected units
- 980
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- DYKMBNDL116I UDI-DI 10198459644764 Lots 26ABL226 26BBD710
Distribution
Part of a larger recall action
This product is one of 9 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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