Medline Convenience Kits Containing Bard Silastic Foley Catheters Recalled Due to Surface Material
Medline Industries, LP is recalling 980 Medline convenience kits containing Bard Silastic Foley Catheters because excess raw material on the catheter surface 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: The product is a medical device with a potential hazard where the excess material 'ay be harmful,' and it is classified as FDA Class II.
Plain-English summary
Medline Industries, LP is recalling Medline convenience kits that contain Bard Silastic Foley Catheters (French sizes 16, 18, 20) with 5cc balloons. The affected kits are identified by code DYNJT6105 and UDI-DI 10198459539381, specifically lots 25JBM474 and 25LBS203.
The manufacturer initiated this recall because an increased amount of raw material was found on the surface of the catheters. This issue may cause the catheters to exhibit staining on the surface, and the excess raw material may be harmful to users.
These kits were distributed nationwide in the states of CA, FL, MD, PA, and TX. Users should check their inventory for the affected lot numbers.
The recalled product
- Product
- Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. NON MB DAVINCI LITHOTOMY SM PK DYNJT6105
- Manufacturer
- Medline Industries, LP
- 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)
- DYNJT6105 UDI-DI 10198459539381 Lots 25JBM474 25LBS203
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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- HighMedline Convenience Kits Containing Bard Silastic Foley Catheters Recalled Due to Surface Contamination
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- HighMedline Convenience Kits Containing Bard Silastic Foley Catheters Recalled Due to Surface Material
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