American Contract System Convenience Kit Recalled for Performance Failures
American Contract Systems Inc is recalling 30 units of Convenience Kits containing Medline catheters because samples failed performance specifications.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
American Contract Systems Inc is recalling 30 units of the American Contract System Convenience Kit, CV B PACK (Model/Catalog Number: TNCB10AM). The kits contain Medline Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays.
Medline Industries, LP identified that representative samples of the product did not meet applicable performance specifications. The recall is classified as Class II by the FDA.
The affected units were distributed nationwide in Iowa and Ohio. The specific lot number is 42-8493811, with a UDI of 191072232991 and an expiration date of 7/15/2026. Consumers should stop using the product and contact the recalling firm for instructions.
The recalled product
- Product
- American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AM
- Manufacturer
- American Contract Systems Inc
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 30
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)
- Lot Code: Lot Number: 42-8493811 UDI: 191072232991 Expiration Date: 7/15/2026
Distribution
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