American Contract System Convenience Kit Recalled for Performance Failures
American Contract Systems Inc is recalling 12 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 specific high-risk pathogens, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
American Contract Systems Inc is recalling 12 units of the American Contract System Convenience Kit, D & C PACK, Model/Catalog Number: LLPD90H. The recall is limited to Lot Number 70-054952 and UDI 191072219947. These kits were distributed in Iowa and Ohio.
The recall was initiated because Medline Industries, LP identified that representative samples of the Medline Red Rubber Intermittent Catheters and Red Rubber Intermittent Catheter Trays contained in the kits did not meet applicable performance specifications. The source text does not specify the exact nature of the performance failure or report any illnesses or injuries.
Consumers who have these specific kits should stop using them and contact American Contract Systems Inc for further instructions.
The recalled product
- Product
- American Contract System Convenience Kit, D & C PACK, Model/Catalog Number: LLPD90H
- Manufacturer
- American Contract Systems Inc
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 12
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: 70-054952 UDI: 191072219947
Distribution
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